Fluid handling system

ABSTRACT

A fluid handling system includes a console configured to connect with a first electrical interface that is configured to connect to a plurality of components of the fluid handling system, the console including a second electrical interface configured to connect with the first electrical interface, a display, and one or more hardware processors. A control system includes the one or more hardware processors and a non-transitory memory storing instructions that, when executed, cause the control system to: detect an electrical signal from a first component of the plurality of components of the fluid handling system responsive to a caretaker performing a first instruction; determine a system state of the fluid handling system based at least in part on the electrical signal from the first component; compare the system state with a predetermined state condition corresponding to said first instruction; and output an indication on the display of the system state.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/920,553, filed Mar. 14, 2018, which is a continuation ofInternational Application No. PCT/US2016/051553, filed Sep. 13, 2016,which claims priority to U.S. Provisional Patent Application Nos.62/218,508, filed Sep. 14, 2015, Provisional Patent Application No.62/218,509, filed Sep. 14, 2015, U.S. Provisional Patent Application No.62/220,040, filed Sep. 17, 2015, and is a Continuation in PartApplication of U.S. application Ser. No. 15/198,342, filed Jun. 30,2016, which claims priority to U.S. application Ser. No. 14/203,978,filed Mar. 11, 2014, which claims priority to U.S. Provisional PatentApplication No. 61/780,656, filed Mar. 13, 2013, the entire contents ofeach of which are incorporated by reference herein in their entiretiesfor all purposes.

BACKGROUND OF THE INVENTION Field of the Invention

This application is directed to pumps for mechanical circulatory supportof a heart. In particular, this application is directed to a console andcontroller for a catheter pump and a fluid handling system configured toconvey and remove fluids to and from the catheter pump.

Description of the Related Art

Heart disease is a major health problem that has high mortality rate.Physicians increasingly use mechanical circulatory support systems fortreating heart failure. The treatment of acute heart failure requires adevice that can provide support to the patient quickly. Physiciansdesire treatment options that can be deployed quickly andminimally-invasively.

Intra-aortic balloon pumps (IABP) are currently the most common type ofcirculatory support devices for treating acute heart failure. IABPs arecommonly used to treat heart failure, such as to stabilize a patientafter cardiogenic shock, during treatment of acute myocardial infarction(MI) or decompensated heart failure, or to support a patient during highrisk percutaneous coronary intervention (PCI). Circulatory supportsystems may be used alone or with pharmacological treatment.

In a conventional approach, an IABP is positioned in the aorta andactuated in a counterpulsation fashion to provide partial support to thecirculatory system. More recently, minimally-invasive rotary blood pumpshave been developed in an attempt to increase the level of potentialsupport (i.e., higher flow). A rotary blood pump is typically insertedinto the body and connected to the cardiovascular system, for example,to the left ventricle and the ascending aorta to assist the pumpingfunction of the heart. Other known applications pumping venous bloodfrom the right ventricle to the pulmonary artery for support of theright side of the heart. An aim of acute circulatory support devices isto reduce the load on the heart muscle for a period of time, tostabilize the patient prior to heart transplant or for continuingsupport.

There is a need for improved mechanical circulatory support devices fortreating acute heart failure. Fixed cross-section ventricular assistdevices designed to provide near full heart flow rate are either toolarge to be advanced percutaneously (e.g., through the femoral arterywithout a cutdown) or provide insufficient flow.

There is a need for a pump with improved performance and clinicaloutcomes. There is a need for a pump that can provide elevated flowrates with reduced risk of hemolysis and thrombosis. There is a need fora pump that can be inserted minimally-invasively and provide sufficientflow rates for various indications while reducing the risk of majoradverse events. In one aspect, there is a need for a heart pump that canbe placed minimally-invasively, for example, through a 15FR or 12FRincision. In one aspect, there is a need for a heart pump that canprovide an average flow rate of 4 Lpm or more during operation, forexample, at 62 mmHg of head pressure. While the flow rate of a rotarypump can be increased by rotating the impeller faster, higher rotationalspeeds are known to increase the risk of hemolysis, which can lead toadverse outcomes and in some cases death. Accordingly, in one aspect,there is a need for a pump that can provide sufficient flow atsignificantly reduced rotational speeds. These and other problems areovercome by the inventions described herein.

Furthermore, in various catheter pump systems, it can be important toprovide fluids to an operative device of a catheter assembly (e.g., forlubrication of moving parts and/or treatment fluids to be delivered tothe patient), and to remove waste fluids from the patient's body. Acontroller may be provided to control the flow into and out of thecatheter assembly. It can be advantageous to provide improved mechanismsfor engaging the catheter assembly with the controller, which may behoused in a console.

Additionally, there is a need to reduce the time to implantation andtreatment. In the case of therapy for acute heart failure in particular,the time it takes to start therapy can be critical to survival and goodoutcomes. For example, a difference of several minutes can be thedifference between recovery and permanent brain damage for patientssuffering myocardial infarction or cardiogenic shock. Accordingly, acontinuing need exists to provide pump systems that can be set up,primed, and inserted faster, easier, and more effectively.

It can be challenging to prepare the catheter pump system for atreatment procedure, and to automatically control the treatmentprocedure. For example, there may be an increased risk of user errorand/or longer treatment preparation times. Conventional catheter pumpsmay provide the user or clinician with unclear guidance on how toproceed at various points during the procedure. Moreover, inconventional systems, it may take the user or clinician a considerableamount of time to prepare the system for use, which may unduly delay thetreatment procedure. Furthermore, it can be challenging to prepareand/or operate the catheter pump system in arrangements that utilize anexpandable impeller and/or an expandable cannula in which the impelleris disposed. For example, it can be challenging to account forexpandable volume of the cannula during system preparation and/oroperation. Furthermore, the parameters of the catheter pump system maydeviate from norms in some instances and the deviation may not be easilyidentified by the user.

These and other problems are overcome by the inventions describedherein.

SUMMARY

There is an urgent need for a pumping device that can be insertedpercutaneously and also provide full cardiac rate flows of the left,right, or both the left and right sides of the heart when called for.

In one embodiment, a fluid handling system includes a console configuredto connect with a first electrical interface that is configured toconnect to a plurality of components of the fluid handling system, theconsole including a second electrical interface configured to connectwith the first electrical interface, a display, and one or more hardwareprocessors. A control system includes the one or more hardwareprocessors and a non-transitory memory storing instructions that, whenexecuted, cause the control system to: detect an electrical signal froma first component of the plurality of components of the fluid handlingsystem responsive to a caretaker performing a first instruction;determine a system state of the fluid handling system based at least inpart on the electrical signal from the first component; compare thesystem state with a predetermined state condition corresponding to saidfirst instruction; and output an indication on the display of the systemstate.

In another embodiment, a removable interface member for a fluid handlingsystem is disclosed. The interface member can include an interface bodysized and shaped to be inserted into an interface aperture of a consolehousing. An electrical component can be disposed on the interface body.Furthermore, an occlusion bed can be disposed on the interface body. Atube segment can be disposed on the interface body near the occlusionbed. The interface body can be dimensioned such that when the interfacebody is inserted into the interface aperture of the console housing, apump in the console housing is operably engaged with the tube segmentand the occlusion bed, and an electrical interconnect in the consolehousing is electrically coupled with the electrical component on theinterface body.

In yet another embodiment, a method for operably coupling an infusionsystem to a console housing is disclosed. The method can comprisepositioning an interface body of the infusion system in an interfaceaperture of the console housing. The interface body can comprise anocclusion bed, a tube segment mounted on the interface body near theocclusion bed, and an electrical component. The method can furthercomprise inserting the interface body through the interface apertureuntil a pump roller of the console housing compresses the tube segmentagainst the occlusion bed and until an electrical interconnect of theconsole housing is electrically coupled to the electrical component ofthe interface body.

In another embodiment, a method for priming a catheter assembly isdisclosed. The catheter assembly can include an elongate body and anoperative device. The method can comprise inserting the operative deviceof the catheter assembly into a priming vessel. The method can furthercomprise securing a proximal portion of the priming vessel to a distalportion of the elongate body, such that the elongate body is in fluidcommunication with the priming vessel. Fluid can be delivered throughthe elongate body and the priming vessel to expel air within thecatheter assembly.

In certain embodiments, a control system for controlling priming of acatheter assembly is disclosed. The control system can include one ormore hardware processors. The one or more hardware processors can beprogrammed to generate a first user interface including a firstinstruction corresponding to priming of a catheter assembly to removegas from the catheter assembly prior to a treatment procedure. The oneor more hardware processors can be further configured to monitor one ormore sensors of a fluid handling system, the fluid handling systemconfigured to prime the catheter assembly to remove the gas. The one ormore hardware processors can determine a system condition based in parton the monitoring of the one or more sensors. Further, the one or morehardware processors can control an operation of a component of the fluidhandling system based on the determined system condition. In anembodiment, the operation includes directing fluid distally through thecatheter assembly to remove the gas.

In certain embodiments, a control system for controlling priming of acatheter assembly can include one or more hardware processors. The oneor more hardware processors can be programmed to generate a first userinterface including a first instruction corresponding to priming of acatheter assembly to remove gas from the catheter assembly prior to atreatment procedure. The one or more hardware processors can be furtherconfigured to monitor one or more sensors of a fluid handling system,the fluid handling system configured to prime the catheter assembly toremove the gas. The one or more hardware processors can determine asystem condition based in part on the monitoring of the one or moresensors. Further, the one or more hardware processors can generate analarm based on the determined system condition. In an embodiment, theone or more hardware processors can also control an operation of acomponent of the fluid handling system based on the determined systemcondition and/or the alarm.

The control system of the preceding two paragraphs can have anysub-combination of the following features: wherein the determination ofthe system condition includes determining the first instruction wascompleted; wherein the determination of the system condition furtherincludes determining the first instruction was completed based on a userinput; wherein the determination of the system condition furtherincludes determining operating parameters of a motor; wherein the motorcan drive a pump that directs fluid distally through the catheterassembly to remove the gas; wherein the system condition includes gas inpressurized saline supply line or reduced saline flow to a lumen of thecatheter assembly; wherein the system condition includes temperature ofa motor over a threshold temperature; wherein the system conditionincludes a flow rate below a threshold; wherein the system conditionincludes connection state of at least one of a plurality of componentsof the fluid handling system; wherein the one or more hardwareprocessors can determine the connection state based on a flow of currentacross two electrical terminals; wherein at least one of the pluralityof components comprise a cassette, wherein the cassette can include apuck; wherein the one or more hardware processors can additionallycontrol operation of an impeller to pump blood based on the determinedsystem condition; wherein the one or more hardware processors canfurther control operation of an impeller motor that imparts rotation tothe impeller to pump the blood; determine a current drawn by theimpeller motor; compare the drawn current with a current threshold; shutdown the impeller motor based on the comparison; determine a flow rategenerated by the impeller motor; determine a speed of the impellermotor; control operation of the impeller motor based on at least two ofthe following: the determined flow rate, the speed, and the drawncurrent; wherein the system condition includes volume of saline in asaline bag; wherein the system condition includes at least one of:blockage in outer sheath and reduced pressure in the outer sheath;wherein the system condition includes a volume of waste bag over athreshold; wherein the system condition includes an amount time ofcannula in the patient over a threshold; wherein the system conditionincludes a battery status; wherein the system condition includes aposition of a cannula; wherein the component includes power electronicsand wherein the one or more hardware processors can transmit a drivesignal to the power electronics, the drive signal can to increase ordecrease power transmitted by the power electronics; wherein thecomponent includes a display and wherein the one or more hardwareprocessors can generate a second user interface and transmit the seconduser interface to the display responsive to the determined systemcondition; wherein the component includes an alarm that can provide anindication to a user; wherein the one or more sensors comprise one ormore pressure sensors; wherein the one or more sensors include one ormore Hall sensors; wherein the one or more sensors include one or moretemperature sensors; wherein the one or more sensors include one or morebubble detector sensors; wherein the one or more sensors include atleast one of the following electrical circuit components: a resistor, aconstant current source, and a constant voltage source; wherein the oneor more hardware processors can detect connection state between acassette and a console of the fluid handling system, send instructionsto begin priming based on the detected connection state between thecassette and the console and the determined system state; wherein thedetection of the connection state includes measuring a flow of currentor voltage across two electrical terminals; wherein the componentincludes an impeller motor that can rotate an impeller to pump blood;wherein the one or more hardware processors can generate an alarm basedon the determined system condition.

In certain embodiments, a method controlling priming of a catheterassembly can include generating a first user interface including a firstinstruction corresponding to priming of a catheter assembly to removegas from the catheter assembly prior to a treatment procedure. Themethod can further include monitoring one or more sensors of a fluidhandling system, the fluid handling system configured to prime thecatheter assembly to remove the gas. The method can additional includethe step of determining a system condition based in part on themonitoring of the one or more sensors. In some embodiment, the methodcan further include controlling an operation of a component of the fluidhandling system based on the determined system condition. In anembodiment, the operation includes directing fluid distally through thecatheter assembly to remove the gas.

The method of the preceding paragraph can have any sub-combination ofthe following features: wherein the detection of the connection statecomprises measuring a flow of current or voltage across two electricalterminals wherein the sending instructions comprises sending a drivesignal to a motor configured to drive a pump that directs fluid distallythrough the catheter assembly to remove the gas. The method of thepreceding paragraph can also include any of the features described inparagraph 19 above.

In some embodiments, a control system can control operation of acatheter assembly. The control system can include one or more hardwareprocessors. The one or more hardware processors can transmit a drivesignal to an impeller motor configured to impart rotation to an impellerto pump blood. The one or more hardware processors can receiveelectrical signals from at least one of the following: a plurality ofsensors, a cassette connector, and the impeller motor. The one or morehardware processors can determine one or more motor parameters from thereceived electrical signals. The one or more hardware processors canalso change operating parameters of the impeller motor based on thedetermined one or more motor parameters, thereby controlling pumping ofblood.

The control system of the preceding paragraph can have anysub-combination of the following features: wherein the one or more motorparameters include a current drawn by the impeller motor; wherein theone or more hardware processors can compare the current drawn by theimpeller motor to a threshold current; the threshold current includes avalue greater than 1 ampere; wherein the one or more motor parametersinclude a flow rate generated by the impeller motor; wherein the one ormore motor parameters include a temperature of the impeller motor;wherein the one or more motor parameters include a motor speed; whereinthe changing of operating parameters of the impeller motor based on thedetermined motor parameters includes comparing the determined one ormore motor parameters to one or more predetermined thresholds. In anembodiment, the control system of the preceding paragraph can use any ofthe features described in paragraph 19.

In an embodiment, a fluid handling system can include a console that canconnect with a first electrical interface of a cassette which canconnect to a plurality of components of the fluid handling system. Theconsole can further include a second electrical interface that canconnect with the first electrical interface, a display, and one or morehardware processors. The fluid handling system can include a controlsystem that includes the one or more hardware processors. The controlsystem can detect an electrical signal from a first component of theplurality of components of the fluid handling system responsive to acaretaker performing a first instruction. The control system candetermine a system state of the fluid handling system based at least inpart on the electrical signal from the first component. The controlsystem can compare the system state with a predetermined state conditioncorresponding to said first instruction.

The fluid handling system of the preceding paragraph can have anysub-combination of the following features: wherein the control systemcan generate a first user interface including a visual indication of thefirst instruction; generate a second user interface including a visualindication of a second instruction based at least on the comparisonindicating that the system state is within predetermined state conditionand the first instruction is completed; generate an alarm based at leaston said comparison indicating that the system state is not withinpredetermined state condition; detect connection state between thecassette and the console; send instructions to begin priming based onthe detected connection state between the cassette and the console andthe determined system state; determine a temperature of an impeller motothat rotates the impeller to pump blood and shut off the impeller motorresponsive to the determination of the temperature of the impellermotor; to determine a current drawn by the impeller motor and shut offthe impeller motor responsive to the determination of the current drawnby the impeller motor; to determine blockage of fluid in a catheter andtrigger an alarm based on the determination of blockage. The controlsystem of the fluid handling system of the preceding paragraph can alsoutilize any of the features of paragraph 19.

In some embodiments, a computer storage system including anon-transitory storage device can include stored executable programinstructions. The program instructions can direct a computer system togenerate a first user interface including a first instructioncorresponding to priming of a catheter assembly to remove gas from thecatheter assembly prior to a treatment procedure. The programinstructions can further direct the computer system to monitor one ormore sensors of a fluid handling system, the fluid handling systemconfigured to prime the catheter assembly to remove the gas. The programinstructions can further direct the computer system determine a systemcondition based in part on the monitoring of the one or more sensors.Further, the program instructions can direct the computer system tocontrol an operation of a component of the fluid handling system basedon the determined system condition. In an embodiment, the operationincludes directing fluid distally through the catheter assembly toremove the gas. The program instruction can also direct the computersystem to generate an alarm based on the determined system conditions.In some embodiment, the program instructions can direct the computersystem to use or execute any of the features of paragraph 19.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete appreciation of the subject matter of this applicationand the various advantages thereof can be realized by reference to thefollowing detailed description, in which reference is made to theaccompanying drawings in which:

FIG. 1 is a schematic view of an operative device of a catheter assemblyin position within the anatomy for assisting the left ventricle.

FIG. 2 is a three-dimensional perspective view of a catheter assembly,according to some embodiments.

FIG. 3A is a three-dimensional perspective view of a fluid handlingsystem that includes a console and catheter assembly.

FIG. 3B is a three-dimensional perspective view of an interface regionof the console shown in FIG. 3A.

FIG. 4 is a three-dimensional perspective view of an interface member,according to one embodiment.

FIG. 5A is a three-dimensional perspective view of a cap.

FIG. 5B is a three-dimensional perspective view of an interface memberin an unlocked configuration.

FIG. 5C is a three-dimensional perspective view of an interface memberin a locked configuration.

FIG. 6A is a three-dimensional perspective view of a first side of anelectrical component, according to one embodiment.

FIG. 6B is a three-dimensional perspective view of a second, oppositeside of the electrical component of FIG. 6A.

FIG. 7 is a schematic diagram of an infusate system, according to oneembodiment.

FIG. 8 is an enlarged view of a priming apparatus shown in FIG. 2 .

FIG. 9 illustrates a block diagram of a console and the electricalconnections between the console and the various components of the fluidhandling system, according to one embodiment.

FIG. 10 illustrates a block diagram of the inputs and outputs of acontrol system, according to one embodiment.

FIG. 11 illustrates a flow chart of a process 1100 that can be managedusing the control system, according to one embodiment.

FIG. 12 illustrates a process 1200 for using the control system toassist with the priming process, according to one embodiment.

FIG. 13 illustrates a process 1300 for controlling operation of themotor using the control system, according to one embodiment.

FIG. 14 illustrates an embodiment of a startup user interface, accordingto one embodiment.

FIG. 15 illustrates system setup user interface for changing settingsrelated to the console, according to one embodiment.

FIG. 16 illustrates a save data user interface generated by the controlsystem, according to one embodiment.

FIG. 17 illustrates a first prep screen user interface generated by thecontrol system, according to one embodiment.

FIG. 18 illustrates a second prep screen user interface generated by thecontrol system, according to one embodiment.

FIGS. 19 to 24 illustrate user interfaces corresponding to instructionsrelating to insertion of cassette (or puck), according to oneembodiment.

FIG. 21 illustrates a user interface corresponding to hanging waste bagon hook, according to one embodiment.

FIG. 22 illustrates user interface generated by the control system forinstructions corresponding to the sixth step in the prepping process,according to one embodiment.

FIG. 23 illustrates a user interface generated by the control systemincluding instruction to unclamp the line connecting to the pressurizedsaline bag, according to one embodiment.

FIG. 24 illustrates a user interface generated by the control systemincluding instructions to insert cassette into the console, according toone embodiment.

FIG. 25 illustrates a user interface generated by the control systemindicating that the cassette was successfully connected with theconsole, according to one embodiment.

FIG. 26 illustrates a user interface displaying the indication ofprogress, according to one embodiment.

FIG. 27 illustrates a user interface generated by the control systemindicating that the priming process has been completed, according to oneembodiment.

FIG. 28 illustrates a user interface including an alert history duringoperation of fluid handling system, according to one embodiment.

FIG. 29 illustrates a user interface for alerting the user when the puckis disconnected, according to one embodiment.

FIG. 30 illustrates a user interface generated by the control systemindicating that there is air in the saline supply line, according to oneembodiment.

FIG. 31 illustrates a user interface generated by the control systembased on a detection of temperature of the handle, according to oneembodiment.

FIG. 32 illustrates a user interface generated by the control system inresponse to monitoring outer sheath pressure, according to oneembodiment.

FIG. 33 illustrates a user interface generated by the control system inresponse to monitoring saline flow, according to one embodiment.

FIG. 34 illustrates a user interface generated by the control system inresponse to detecting outer sheath pressure, according to oneembodiment.

FIG. 35 illustrates a user interface generated by the control system inresponse to monitoring the unlock button, according to one embodiment.

FIG. 36 illustrates a user interface generated by the control systembased on monitoring of waste line pressure sensor, according to oneembodiment.

FIG. 37 illustrates a user interface generated by the control systembased on monitoring device in the patient, according to one embodiment.

FIGS. 38, 39, and 40 illustrate user interfaces generated by the controlsystem in response to monitoring temperature, according to oneembodiment.

FIG. 41 illustrates a user interface generated by the control system inresponse to monitoring connection status of the puck, according to oneembodiment.

FIGS. 42 to 45 illustrate user interfaces generated by the controlsystem in response to monitoring cannula position, according to oneembodiment.

More detailed descriptions of various embodiments of components forheart pumps useful to treat patients experiencing cardiac stress,including acute heart failure, are set forth below.

DETAILED DESCRIPTION

This application is directed to fluid handling systems that areconfigured to control and/or manage fluid and electrical pathways in acatheter assembly, such as a catheter assembly of a percutaneous heartpump system. In particular, the disclosed percutaneous heart pumpsystems may include a catheter assembly and a console that includes acontroller configured to control the fluid and electrical pathways thatpass through the catheter assembly. Some of the disclosed embodimentsgenerally relate to various configurations for coupling and engaging thecatheter assembly with the console. For example, the console may beconfigured to control the flow rate of the pump and to monitor variousphysiological parameters and pump performance through the variouselectrical and fluid pathways of the catheter assembly. In somearrangements, the catheter assembly may be disposable, such that thecatheter assembly can be discarded after use, while the console andcontroller are reusable. In embodiments with a reusable console and adisposable catheter assembly (or, indeed, in any embodiments whereconsoles and catheter assemblies may be coupled), it can be desirable toprovide an effective interface between the catheter assembly and theconsole that completes the various fluid and electrical connectionsbetween the catheter assembly and the console.

In particular, it can be advantageous to provide an interface member ata proximal portion of the catheter assembly that is removably engageablewith the console. Furthermore, to enhance usability and to minimizemistakes in making the connections, it can be important to make theinterface easy to use so that users can easily connect the catheterassembly to the console before use and easily remove the catheterassembly from the console after use. Moreover, it can be important thatthe interface provides a secure connection between the interface memberof the catheter assembly and an interface region of the console toensure that the catheter assembly remains connected to the consoleuninterrupted during treatment.

As explained herein, one example of a catheter assembly is used in apercutaneous heart pump system having an operative device (e.g., animpeller assembly) that is configured to assist the patient's heart inpumping blood. The heart pump system may be configured to at leasttemporarily support the workload of the left ventricle in someembodiments. The exemplary heart pump can be designed for percutaneousentry through the femoral artery to a patient's heart. In particular,the exemplary impeller assembly can include a collapsible impeller andcannula, which can be inserted into the patient's vasculature at acatheter size of less than 13 FR, for example, about 12.5 FR in somearrangements. During insertion through the patient's vascular system tothe heart, a sheath may maintain the impeller and cannula assembly in astored configuration. When the impeller assembly is positioned in theleft ventricle (or another chamber of a patient's heart), the impellerand cannula can expand to a larger diameter, for example to a cathetersize of about 24 FR when the sheath is removed from the impellerassembly. The expanded diameter of the impeller and cannula may allowfor the generation of higher flow rates, according to some embodiments.

For example, FIG. 1 illustrates one use of the disclosed catheter pumpsystem. A distal portion of the pump, which can include an impellerassembly 116A, is placed in the left ventricle (LV) of the heart to pumpblood from the LV into the aorta. The pump can be used in this way totreat patients with a wide range of conditions, including cardiogenicshock, myocardial infarction, and other cardiac conditions, and also tosupport a patient during a procedure such as percutaneous coronaryintervention. One convenient manner of placement of the distal portionof the pump in the heart is by percutaneous access and delivery usingthe Seldinger technique, or other methods familiar to cardiologists.These approaches enable the pump to be used in emergency medicine, acatheter lab and in other non-surgical settings. Modifications can alsoenable the pump 10 to support the right side of the heart. Examplemodifications that could be used for right side support includeproviding delivery features and/or shaping a distal portion that is tobe placed through at least one heart valve from the venous side, such asis discussed in U.S. Pat. Nos. 6,544,216; 7,070,555; and US2012-0203056A1, all of which are hereby incorporated by reference hereinin their entirety for all purposes.

Turning to FIG. 2 , a three-dimensional perspective view of a catheterassembly 100A is disclosed. The catheter assembly 100A may correspond tothe disposable portion of the heart pump systems described herein. Forexample, the catheter assembly 100A may include the impeller assembly116A near a distal portion of the catheter assembly 100A, an elongatebody 174A extending proximally from the impeller assembly 116A, aninfusion system 195 configured to supply infusate to the catheterassembly 100A, a motor assembly comprising a driven assembly 101 and adrive assembly 103, one or more conduits 302 (e.g., electrical and/orfluid conduits) extending proximally from the motor assembly, and aninterface member 300 coupled at a proximal portion of the conduits 302.

Moving from the distal end of the catheter assembly 100A of FIG. 2 tothe proximal end, the impeller assembly 116A may be disposed at a distalportion of the catheter assembly 100A. As explained above, the impellerassembly 116A can include an expandable cannula or housing and animpeller with one or more blades. As the impeller rotates, blood can bepumped proximally (or distally in some implementations) to function as acardiac assist device. A priming apparatus 1400 can be disposed over theimpeller assembly 116A. As explained herein with reference to FIGS. 7-8, the priming apparatus 1400 can be configured to expedite a process ofexpelling air from the catheter assembly 100A before insertion of theoperative device of the catheter assembly into the patient.

With continued reference to FIG. 2 , the elongate body 174A extendsproximally from the impeller assembly 116A to an infusion system 195configured to allow infusate to enter the catheter assembly 100A andwaste fluid to leave the catheter assembly 100A. A catheter body 120A(which also passes through the elongate body 174A) can extend proximallyand couple to the driven assembly 101 of the motor assembly. Thecatheter body 120A can pass within the elongate body 174A, such that theelongate body 174A can axially translate relative to the catheter body120A. Axial translation of the elongate body 174A relative to thecatheter body 120A can enable the expansion and collapse of the impellerassembly 116A. For example, the impeller assembly 116A, coupled to adistal portion of the catheter body 120A, may expand into an expandedstate by moving the elongate body 174A proximally relative to theimpeller assembly 116A. The impeller assembly 116A may self-expand intothe expanded state in some embodiments. In the expanded state, theimpeller assembly 116A is able to pump blood at high flow rates. Afterthe treatment procedure, the impeller assembly 116A may be compressedinto a collapsed state by advancing a distal portion 170A of theelongate body 174A distally over the impeller assembly 116A to cause theimpeller assembly 116A to collapse.

As explained above, the catheter body 120A can couple to the drivenassembly 101 of the motor assembly. The driven assembly 101 can beconfigured to receive torque applied by the drive assembly 103, which isshown as being decoupled from the driven assembly 101 and the catheterassembly 100A in FIG. 2 . The drive assembly 103 can be coupled to thedriven assembly 101 by engaging a proximal portion of the drivenassembly 101 with the drive assembly, e.g., by inserting the proximalportion of the driven assembly 101 into an aperture 105 of the driveassembly 103.

Although not shown in FIG. 2 , a drive shaft can extend from the drivenassembly 101 through the catheter body 120A to couple to an impellershaft at or proximal to the impeller assembly 116A. The drive assembly103 can electrically communicate with a controller in a console (see,e.g., FIGS. 3A-3B), which can be configured to control the operation ofthe motor assembly and the infusion system 195 that supplies a flow ofinfusate in the catheter assembly 100A. The impeller of the impellerassembly 116A may thus be rotated remotely by the motor assembly duringoperation of the catheter pump in various embodiments. For example, themotor assembly can be disposed outside the patient. In some embodiments,the motor assembly is separate from the controller or console, e.g., tobe placed closer to the patient. In other embodiments, the motorassembly is part of the controller. In still other embodiments, themotor assembly is miniaturized to be insertable into the patient. Suchembodiments allow the drive shaft to be much shorter, e.g., shorter thanthe distance from the aortic valve to the aortic arch (about 5 cm orless). Some examples of miniaturized motors catheter pumps and relatedcomponents and methods are discussed in U.S. Pat. Nos. 5,964,694;6,007,478; 6,178,922; and 6,176,848, all of which are herebyincorporated by reference herein in their entirety for all purposes.

As shown in FIG. 2 , the motor assembly (e.g., the drive assembly 103and the driven assembly 101) is in electrical communication with thecontroller and console by way of the conduits 302, which may includeelectrical wires. In particular, as shown in FIG. 2 , the electricalwires may extend from the motor assembly proximally to the interfacemember 300. To enable the controller in the console to electricallycommunicate with the motor assembly and/or other sensors in the catheterassembly 100A (such as pressure sensors, flow sensors, temperaturesensors, bubble detectors, etc.), it can be advantageous to provide areliable electrical connection between the interface member 300 and theconsole. In various embodiments disclosed herein, therefore, theremovable interface member 300 may include electrical componentsconfigured to couple to one or more electrical contacts (sometimesreferred to herein as interconnections) in the console. The electricalconnections may be achieved in a simple, user-friendly manner. Invarious embodiments disclosed herein, for example, the electricalconnections may be made substantially at the same time, e.g.,substantially simultaneously, as fluid connections are made between theinterface member 300 and console. These and other structuresincorporated to reduce the complexity of operating the pump system areprovided to reduce the chance of errors in set-up and delays, which forthe emergency conditions in which the pump may be implemented could belife-threatening.

The mechanical components rotatably supporting the impeller within theimpeller assembly 116A permit high rotational speeds while controllingheat and particle generation that can come with high speeds. Theinfusion system 195 may deliver a cooling and lubricating solution tothe distal portion of the catheter assembly 100A for these purposes. Asshown in FIG. 2 , the infusion system 195 may be in fluid communicationwith the interface member 300 by way of the conduits 302, which may alsoinclude fluid conduits or tubes. Because the catheter assembly 100A maybe disposable and/or removable from a console, it can be important tosecurely couple interface member 300 to the console. Furthermore, it canbe important to provide an easy-to-use interface such that users caneasily complete fluid connections that remain secure during a treatmentprocedure. Maintaining security of the connection is important becausethe fluids and signals carried by the conduits 302 enable the impellerto operate in a continuous manner. Stoppage of the pump system mayrequire the catheter assembly 100A to be removed from the patient andreplaced in certain circumstances, which may be life-threatening orextremely inconvenient at a minimum.

When activated, the catheter pump system can effectively increase theflow of blood out of the heart and through the patient's vascularsystem. In various embodiments disclosed herein, the pump can beconfigured to produce a maximum flow rate (e.g. low mm Hg) of greaterthan 4 Lpm, greater than 4.5 Lpm, greater than 5 Lpm, greater than 5.5Lpm, greater than 6 Lpm, greater than 6.5 Lpm, greater than 7 Lpm,greater than 7.5 Lpm, greater than 8 Lpm, greater than 9 Lpm, or greaterthan 10 Lpm. In various embodiments, the pump can be configured toproduce an average flow rate at 62 mmHg pressure head of greater than 2Lpm, greater than 2.5 Lpm, greater than 3 Lpm, greater than 3.5 Lpm,greater than 4 Lpm, greater than 4.25 Lpm, greater than 4.5 Lpm, greaterthan 5 Lpm, greater than 5.5 Lpm, or greater than 6 Lpm.

Various aspects of the pump and associated components are similar tothose disclosed in U.S. Pat. Nos. 7,393,181; 8,376,707; 7,841,976;7,022,100; and 7,998,054, and in U.S. Pub. Nos. 2011/0004046;2012/0178986; 2012/0172655; 2012/0178985; and 2012/0004495, the entirecontents of each of which are incorporated herein for all purposes byreference. In addition, this application incorporates by reference inits entirety and for all purposes the subject matter disclosed in eachof the following concurrently filed applications: application Ser. No.13/802,556, entitled “DISTAL BEARING SUPPORT,” filed on Mar. 13, 2013;application Ser. No. 13/801,833, entitled “SHEATH SYSTEM FOR CATHETERPUMP,” filed on Mar. 13, 2013; application Ser. No. 13/802,570, entitled“IMPELLER FOR CATHETER PUMP,” filed on Mar. 13, 2013; application Ser.No. 13/801,528, entitled “CATHETER PUMP,” filed on Mar. 13, 2013; andapplication Ser. No. 13/802,468, entitled “MOTOR ASSEMBLY FOR CATHETERPUMP,” filed on Mar. 13, 2013.

Fluid Handling System

FIG. 3A is a three-dimensional perspective view of a fluid handlingsystem 350 that includes a console 301 and the catheter assembly 100A ofFIG. 2 . The console 301 can provide electrical power, control signals,medical fluids (e.g., saline) for infusion, and fluid waste extractionto the catheter assembly 100A by way of its interface with the interfacemember 300. In this manner, a plurality of fluid connections canadvantageously be made with a single interface. As illustrated in FIG. 2, for example, the removable interface member 300 may be disposed at aproximal portion of the catheter assembly 100A and may be configured tocouple to the console 301 at an interface region 303.

In some embodiments, the fluid handling system 350 can be configured todeliver fluids to and/or remove fluids from the catheter assembly 100A.As discussed above and in the incorporated patent references, salineand/or other medical solutions can lubricate and/or cool componentbetween the motor assembly and the operative device. If desired, wastefluids can be removed from the catheter assembly 100A using the fluidhandling system 350. In some embodiments, the fluid handling system 350can include a multilumen catheter body having a proximal end and adistal end. The catheter body can include one or more lumens throughwhich medical solutions (e.g., saline), waste fluids, and/or blood canflow. To drive fluid through the catheter assembly 100A (e.g., intoand/or out of the catheter assembly 100A), the console 301 may includeone or more pump(s) configured to apply positive or negative pressure tothe catheter assembly 100A when the catheter assembly 100A is coupled tothe console 301 and engages the pump(s).

In addition, the fluid handling system 350 may also be configured toprovide electrical communication between the console 301 and thecatheter assembly 100A. For example, the console can include acontroller (e.g., a processor) that is programmed to control and/ormanage the operation of the motor assembly. The console 301 may alsoinclude electrical interfaces configured to supply power to the motorassembly and/or other components that are driven by electrical powerwhen the interface member 300 is coupled to the console 301. Moreover,one or more electrical or electronic sensors may be provided in thecatheter assembly 100A and may electrically couple to the console 301 byway of the fluid handling system 350. The embodiments disclosed hereinmay thereby provide fluid and electrical connections between thecatheter assembly 100A and the console 301.

As explained above, the fluid handling system 350 may provide aremovable interface between the catheter assembly 100A and the console301, which may include various components, including, e.g., one or morepump(s), processors (e.g., the controller), electrical interconnections,etc. For example, to activate one or more pumps in the console 301and/or to engage one or more electrical connections between the console301 and the interface member 300, a user may simply insert a distalportion of the interface member 300 (e.g., including a closure member)along the illustrated Z-direction into an aperture 304 of the interfaceregion 303 until the pump(s) are engaged and the electricalconnection(s) are formed. In some aspects, the insertion of theinterface member along the Z-direction may engage the pump(s) andcomplete the electrical connection(s) substantially simultaneously.

In some embodiments, the interface member 300 may be secured to theconsole 301 by engaging a locking device between the interface region303 and the interface member 300. One convenient way to engage a lockingdevice is by rotating a portion of the interface member 300 relative toanother portion of the interface member or relative to the console 301,as explained herein. For example, rotation of an outermost structure(opposite the direction Z), sometimes referred to herein as a “cap”relative to the console may engage a locking mechanism configured tomechanically secure the interface member 300 to the console 301 toprevent the interface member 300 from being accidentally disengagedduring a treatment procedure.

The console 301 may also include a user interface 312, which maycomprise a display device and/or a touch-screen display. The user mayoperate the percutaneous heart pump system by interacting with the userinterface 312 to select, e.g., desired flow rates and other treatmentparameters. The user may also monitor properties of the procedure on theuser interface 312.

FIG. 3B is a three-dimensional perspective view of the interface region303 of the console 301 shown in FIG. 3A. The interface region 303 caninclude the aperture 304 configured to receive the distal portion of theinterface member 303. The aperture 304 may include a generally circularcavity shaped and sized to receive a portion of the interface member300. A bubble detector 308 (e.g., an optical sensor in some embodiments)can be positioned at a back wall of the aperture 304. The bubbledetector 308 may include a recess portion defined by two walls sized andshaped to receive a segment of tubing. When fluid flows through thetubing (see, e.g., bubble detector tube segment 326 in FIG. 4 ), thebubble detector 308 may monitor the fluid to determine whether or notthe fluid includes unwanted matter, e.g., bubbles of air or other gas.In some embodiments, the bubble detector 308 may measure the amount(number or volume) of bubbles in the fluid passing though the tubesegment. It should be appreciated that it can be important to detectbubbles in the treatment fluid to avoid inducing embolisms in thepatient. The bubble detector 308 may electrically communicate with thecontroller in the console 301 and can indicate the amount of bubbles inthe treatment fluid. The console 301, in turn, can alert the user ifthere are bubbles in the treatment fluid.

The interface region 303 can also include one or more pumps, e.g.,peristaltic pumps in some embodiments. The peristaltic pumps can be usedto pump fluid into or out of the catheter assembly 100A to delivermedical fluids and to remove waste fluids, respectively. Such pumps mayemploy one or more rollers 306 to control delivery of a fluid within arespective tube (see, e.g., pump tube segments 324 a, 324 b of FIG. 4 ).For example, the one or more pump rollers 306 can be housed within theconsole 301. As shown, two pump rollers 306 are mounted about theirrotational axes (e.g., the Y-direction illustrated in FIG. 3B) at theback wall of the aperture 304. The pump rollers 306 can be rotated by aperistaltic pump motor within the console (not shown in FIGS. 3A-3B). Asexplained in more detail herein with respect to FIG. 4 below, therollers 306 can engage pump tube segments 324 a, 324 b to pump fluidinto or out of the catheter assembly 100A. The pump rollers 306 may beconfigured to be received within occlusion bed regions of the interfacemember 300 (see, e.g., occlusion beds 322 a and 322 b of FIG. 4 ) topump fluid through the catheter assembly 100A.

An electrical interconnect 307 can also be provided in the back wall ofthe aperture 304. The electrical interconnect 307 can be configured toprovide power to the motor assembly and/or electrical signals orinstructions to control the operation of the motor assembly. Theelectrical interconnect 307 can also be configured to receive electricalsignals indicative of sensor readings for monitoring pressure, flowrates, and/or temperature of one or more components in the catheterassembly 100A. A recessed channel 309 can extend from the bottom of theaperture 304 along the side to the lower edge of the console 301. Therecessed channel 309 can be shaped and sized to receive one or more ofthe conduits 302 (e.g., electrical and/or fluid conduits) extendingbetween the interface member 300 and the motor assembly. In oneembodiment, all of the conduits 302 can be received within the channel309 providing a flush side surface when the interface member 300 isdisposed in the interface aperture 304.

In addition, it can be important to ensure that the interface member 300is controllably secured within the console 301 such that it is engagedand disengaged only when the user desires to engage or disengage theinterface member 300 from the console 301. For example, as explained inmore detail herein relative to FIGS. 5A-5C, the interface region 303 caninclude a groove 313 sized and shaped to receive a locking mechanism(e.g., a tab or flange projecting in the X direction) on the interfacemember 300. In one embodiment, a disengaging member 305 includes aspring-loaded release mechanism 310 provided above the aperture 304 anda pin 311 that can be inserted into a hole in the interface member 300(see, e.g., FIGS. 5A-5C and the accompanying disclosure below). Asexplained below with respect to FIGS. 5A-5C, the pin 311 can assist inreleasing the interface member 300 relative to the console 301. Thespring-loaded release mechanism 310 can be pressed to release the pin311 and unlock the interface member 300 from the console 301. Asexplained herein, the spring-loaded release mechanism 310 can thereforeact as a further safety mechanism to ensure that the cassette is notaccidentally disengaged by the user.

Removable Interface Member

FIG. 4 is a three-dimensional perspective view of the interface member300, according to one embodiment. The interface member 300 can comprisea body that is shaped and sized to fit into the interface region 303 ofthe console 301. As shown in FIG. 4 , the interface member 300 can havea substantially circular profile, and is sometimes referred to as apuck. In some embodiments, the interface member 300 can include an outerbody 333 operably coupled to a manual interface 320, sometimes referredto as a cap. The manual interface 320 is generally palm-sized so that auser can receive it in their hand and operate it comfortably, e.g., withfinger pressure on the outer rim of the cap. One or more occlusion bedscan be formed or provided at the interface between the interface member300 and the console 301, e.g., in or on the interface member 300. Forexample, first and second occlusion beds 322 a and 322 b may be formedin the interface member 300. As shown in FIG. 4 , for example, theocclusion beds 322 a, 322 b, can include arcuate recessed regions formedin the interface member 300.

The interface member 300 can further include first and second pump tubesegments 324 a, 324 b positioned along the occlusion beds 322 a, 322 bformed in the interface member 300. When the interface member 300 isinserted into the console 301, the pump rollers 306 can engage with theinterface member 300 and compress the tube segment(s) 324 a, 324 bagainst the occlusion bed(s) 322 a, 322 b, respectively. As the pumpmotor(s) in the console 301 rotate the rollers 306, fluid flows intouncompressed portions of the tube segment(s) 324 a, 324 b and continuesflowing throughout the catheter assembly 100A. For example, bycompressing the tube segments 324 a, 324 b, the fluid may be pumped intoor out of the catheter assembly 100A by way of the conduits 302extending from the interface member 300 to the motor assembly anddistally beyond the motor assembly.

Because the tolerances for the peristaltic pump can be rather tight, thebody of the interface member 300 (e.g., the outer body 333 and/or aninner body, such as inner body 339 illustrated in FIGS. 5B-5C) can beformed with precise tolerances (e.g., molded from a unitary structure insome implementations) such that when the interface member 300 isinserted into the console 301, the pump rollers 306 precisely andautomatically engage with the tube segments 324 a, 324 b and occlusionbeds 322 a, 322 b to reliably occlude the tube segments 324 a, 324 b andpump fluids through the catheter assembly 100A. Thus, when the interfacemember 300 is inserted sufficiently far into the interface region 303,the pump in the console 301 can automatically engage the interfacemember 300.

For example, the gap between the rollers 306 and the occlusion beds 322a, 322 b can be less than about two wall thicknesses of the tubesegments 324 a, 324 b in some arrangements, such that the tubes 324 a,324 b can be effectively occluded. Due to the precise tolerances of theinterface member 300, the pump can be engaged by simply inserting theinterface member 300 into the console 301. There is no need toseparately activate the pump in some embodiments. The dimensions of theinterface member 300 may be selected such that the occlusion bed(s) 322a, 322 b automatically engages the respective pump rollers 306 uponinsertion of the interface member 300 into the console 301.

The above configuration provides several advantages. As one of skill inthe art will appreciate from the description herein, the interfacemember 300 and interface region 303 provide an easy-to-use, quickconnection of the tubing segments to one or more respective rollers 306.Moreover, the components can be manufactured easily and cost-effectivelybecause only certain components require tight tolerances and theinterface of member 300 to region 303 is essentially self-aligning. Theinterface also eliminates any need to engage the pump through a secondmechanism or operator step, streamlining operation of the heart pump andsimplifying the engagement of the catheter assembly 100A to the console301. Also, in implementations where the console 301 is mounted on an IVpole with rollers, or another type of lightweight cart, for example, thesimplified engagement mechanisms disclosed herein can be advantageousbecause there is only a minimal applied force against the pole, whichprevents the pole from rolling or tipping when the pump is engaged.

The pump tube segments 324 a, 324 b can be mounted on the interface body300 near or in the respective occlusion beds 322 a, 322 b. Asillustrated, the first and second pump tube segments 324 a, 324 b can beconfigured to engage with the pump rollers 306 in the console 301, asexplained above. The first and second pump tube segments 324 a, 324 bcan have an arcuate shape (which may be pre-formed in variousarrangements) that generally conforms to the curved shape of eachrespective occlusion bed 322 a, 322 b. The pump rollers 306 within theconsole 301 can thereby be positioned within the occlusion beds 322 a,322 b to compress the tube segments 324 a, 324 b against the wall of theocclusion beds 322 a, 322 b. In addition, a bubble detector tube segment326 can also be mounted in or on the interface member 300 and can beconfigured to engage with or be positioned adjacent to the bubbledetector 308 illustrated in FIG. 3B. The bubble detector tube segment326 can be any suitable shape. As illustrated, the bubble detector tubesegment can be substantially straight and can be sized and shaped to bereceived by the bubble detector 308 within the console 301. As explainedabove with respect to FIGS. 3A-3B, the bubble detector 308 (which may bean optical sensor) can be used to detect air bubbles in the treatment orlubricating fluid being supplied to the patient.

The tube segments can be fluidly connected to the remainder of thecatheter assembly 100A, including, e.g., one or more lumens of thecatheter body, by way of the conduits 302. In operation, therefore, theremovable interface member 300 may allow fluid to be pumped into and outof the patient within a controlled system, e.g., such that the fluidswithin the catheter assembly 100A can be pumped while maintaining asterile environment for the fluids. Depending on the implementation, thevolume of medical solution into the catheter body can be equal to, orcan exceed by a minimum amount, the volume of medical solution out ofthe catheter body to assure that blood does not enter a blood-freeportion of the heart pump.

In addition, one or more electrical contacts 328 can be provided in theinterface member 300. The electrical contacts 328 can be any suitableelectrical interface configured to transmit electrical signals betweenthe console 301 and the catheter assembly 100A (e.g., the motor assemblyand/or any suitable sensors). For example, the electrical contacts 328can be configured to electrically couple to the electrical interconnect307 disposed in the console 301. Electrical control signals and/or powermay be transmitted between the console 301 and the catheter assembly100A by way of the electrical connection between the electrical contacts328 and the electrical interconnect 307. Advantageously, the electricalconnection between the electrical contacts 328 and the electricalinterconnect 307 may be formed or completed when the interface member300 is inserted into the interface region 303 of the console 301. Forexample, in some embodiments, the electrical connection between theelectrical contacts 328 and the electrical interconnect 307 may beformed substantially simultaneously with the fluid connection (e.g., theengagement of the pump) when the interface member 300 is inserted intothe interface region 303. In some aspects, for example, the electricalconnection can be formed by inserting electrical pins from theelectrical contacts 328 into corresponding holes of the electricalinterconnect 307 of the console 301, or vice versa.

Further, as shown in FIG. 4 , the manual interface 320 can bemechanically coupled to a proximal portion of the outer body 333 and maybe configured to rotate relative to the outer body 333 in a constrainedmanner, as explained below relative to FIGS. 5A-5C. For example, theouter body 333 can include one or more locking apertures 331 configuredto receive locking tabs 332 that are configured to lock the manualinterface 320 relative to the console 301. Moreover, as explained belowrelative to FIGS. 5A-5C, the outer body 333 may include a pin hole 321sized and shaped to receive the pin 311 illustrated in FIG. 3B toreleasably couple the removable interface member 300 relative to theconsole 301.

One will appreciate from the description herein that the configurationof the pump rollers, occlusion bed, and tubing can be modified dependingon the application in accordance with the present inventions. Forexample, the configuration may be modified to provide easier access forservice and repair. In various embodiments, the pump rollers may bedisposed external to the console. In various embodiments, the pumprollers and occlusion bed may be both disposed within the cassette. Invarious embodiments, the console includes a mechanism to actuate thepump rollers in the cassette. In various embodiments, the rollers may befixed. In various embodiments, the rollers may be configured to rotate,translate, or both. The rollers and/or the occlusion bed may bepositioned on a base that is configured to move. In some embodiments,the console-cassette interface can include a positive pressure interfaceto pump fluid (e.g., saline) into the patient's vasculature and anegative pressure interface to pump fluid (e.g., waste fluid) out of thepatient's vasculature.

Locking Mechanism

As discussed above, the interface member 300 advantageously can be fullyengaged with the console 301 by simply inserting it into acorrespondingly shaped aperture 304 in the housing of the console 301.When interface member 300 is brought into adjacency with a back wall ofthe interface region 303 of the console, e.g., when the interface member300 is inserted into the aperture 304, the fluid handling and electricalconnections are made, and the system 350 is operational. A lockingmechanism in the interface member 300 can be provided for additionalsecurity, which can be particularly useful for patient transport andother more dynamic settings. For example, it is desirable to ensure thatthe catheter assembly 100A is secured to the console 301 during theentire procedure to ensure that the procedure is not disrupted due toaccidental disengagement of the interface member 300 from the console301.

In one embodiment, the locking mechanism can be disposed between theconsole 301 and the interface member 300 and can be configured to beengaged by a minimal movement of an actuator. For example, the manualinterface 320 can be provided to cause engagement of a locking device bya small rotational turn of the manual interface 320 relative to theconsole 301.

FIG. 5A is a three-dimensional perspective view of the manual interface320. As shown in FIG. 5A, the manual interface 320 can include or becoupled with an internal cam 335. The cam 335 can include one or moreprotruding lobes, such as lobes 336 a and 336 b. Further, the cam 335can include a recessed region 337 recessed inwardly relative to thelobes 336 a, 336 b. The cam 335 can also include a stepped region 338which can enable the interface member 300 to be locked and unlockedrelative to the console 301, as explained herein.

FIG. 5B is a three-dimensional perspective view of an interface member300A in an unlocked configuration, and FIG. 5C is a three-dimensionalperspective view of an interface member 300B in a locked configuration.It should be appreciated that the interface members 300A, 300B of FIGS.5B and 5C are illustrated without the outer body 333, which has beenhidden in FIGS. 5B and 5C for purposes of illustration. Unless otherwisenoted, the components of FIGS. 5B and 5C are the same as or similar tothe components illustrated with respect to FIG. 4 . As shown in FIGS. 5Band 5C, the interface members 300A, 300B can include an inner body 339that can be disposed within the outer body 333 shown in FIG. 4 . Theocclusion beds 322 a, 322 b can be formed in the inner body 339 of theinterface member 300A, 300B, as shown in FIGS. 5B-5C; however, in otherarrangements, the occlusion beds 322 a, 322 b may be formed in the outerbody 333 or other portions of the interface member 300A, 300B. Inaddition, as shown in FIGS. 5A and 5B, an electrical component 340 canbe disposed in a recess or other portion of the inner body 339.Additional details regarding the electrical component 340 are explainedbelow with respect to FIGS. 6A-6B.

The inner body 339 of the interface member 300A, 300B can furtherinclude a protrusion 330 that includes the tab 332 at a distal portionof the protrusion 330. When the interface member 300A is in the unlockedconfiguration, the protrusion 330 can be disposed in or near the recess337 of the cam 335 in the manual interface 320. The cam 335 maytherefore not contact or apply a force against the protrusion 330 whenthe interface member 300A is in the unlocked configuration, as shown inFIG. 5B.

However, once the interface member 300 is inserted into the console 301,the interface member 300 can be locked into place by rotating the manualinterface 320 relative to the inner body 339 and the console 301, e.g.,rotated in the A-direction illustrated in FIG. 5B. When the manualinterface 320 is rotated, the internal cam 335 is also rotated withinthe interface member 300A, 300B. Once the cam is rotated, the lobes 336a, 336 b of the cam 335 can engage with the one or more protrusions 330of the inner body 339 and can push the protrusions 330 outwardlyrelative to the inner body 339. In one embodiment, the tabs 332 mayextend outwardly through the locking apertures 331 formed on the outerbody 333. When the tab(s) 332 are pushed through the locking aperture(s)331, the tabs 332 project laterally outward from the outer body 333. Inthis position, in some embodiments, each of the tabs 332 can lock intothe groove(s) 313 in the console 301 (see FIG. 3B) to secure theinterface member 300B to the console 301. Thus, in the unlockedposition, the tab 332 can be substantially flush with the outer surfaceof the interface member 300A, and in the locked position, the tab 332can extend through the locking aperture 331 and lock into the grooves313 in the console 301.

In some embodiments, the protrusion 330 can be a cantilevered protrusionfrom the inner body 339. As mentioned above, it can be important tomaintain tight tolerances between the occlusion beds 322 a, 322 b, whichis also formed in the interface member, and the pump rollers 306 whenthe interface member 300 engages with the console 301. Because theocclusion beds 322 a, 322 b may be formed in the same body as thecantilevered protrusions 330, conventional manufacturing processes, suchas molding processes, can be used to manufacture the interface member300 (e.g., the outer body 333 and/or the inner body 339) according toprecise dimensions. Thus, the protrusion(s) 330, tab(s) 332 and theocclusion bed(s) 322 a, 322 b can be made within tight dimensionaltolerances, and the tab(s) 332 and/or protrusion(s) 330 can bepositioned relative to the occlusion bed(s) 322 a, 322 b with very highprecision such that when the interface member 300 is engaged with theconsole 301, the tube segments 324 a, 324 b are optimally occluded.Moreover, because the interface member 300 can be locked by rotating themanual interface 320 on the interface member 300, only minimal forcesare applied to the console 301. This enhances the advantages ofminimizing disruption of a mobile cart or IV pole to which the systemmay be coupled.

Disengagement Mechanism

It can also be important to provide a disengagement mechanism configuredto decouple the interface member 300 from the console 301. Withreference to FIGS. 3B, 4, 5B, and 5C, the disengaging member 305 of theconsole 301 can be configured to disengage and unlock the interfacemember 300 from the console 301. For example, the pin 311 may bespring-loaded such that when the interface member 300A is in theunlocked configuration, the pin 311 extends through the pin hole 321 ofthe outer body 333 but only contacts a side surface of one of the lobes336 b of the cam 335. Thus, in the unlocked configuration of theinterface member 300A, the pin 311 may simply slide along the camsurface, permitting rotation of the manual interface 320 relative to thepin 311 and the console 301.

As shown in FIGS. 3B and 5C, however, when the interface member 300B isrotated into a locked configuration, the pin 311 can engage with thestepped region 338 of the internal cam 335, e.g., the spring-biased pin311 can extend into the stepped region 338 or shoulder of the cam 335.By engaging the stepped region 338, the pin 311 prevents the cam 335from rotating from the locked configuration to the unlockedconfiguration. A user can disengage the cassette by pressing thespring-loaded release mechanism 310 to release the spring and remove thepin 311 from the stepped region 338. The pin 311 can thereby bedisengaged from the stepped region 338, and the internal cam 335 canrotate back into the unlocked position. When the cam 335 is moved backinto the unlocked position, the tab 332 can be withdrawn from the groove313 in the console 301 to unlock the interface member 300.

Electrical Interconnections, Components, and Cables

FIG. 6A is a three-dimensional perspective view of a first side of theelectrical component 340 illustrated in FIG. 4 . FIG. 6B is athree-dimensional perspective view of a second, opposite side of theelectrical component 340 of FIG. 6A. As shown in FIGS. 5B-5C, theelectrical component 340 may be disposed in a recess of the interfacemember 300. The electrical component 340 can be any suitable electricalor electronic component, including, e.g., a printed circuit board (PCB)configured to provide an electrical interface between various componentsin the catheter assembly 100A and the console 301. As explained herein,the electrical component 340 can form an electrical interface betweenthe interface member 300 and the console 301 to provide electricalcommunication between the console 301 and the catheter assembly 100A(such as the motor assembly and/or various sensors).

For example, the electrical component 340 of the interface member 300can include the one or more electrical contacts 328 configured to matewith the corresponding electrical interconnect 307 in the console 301.The electrical contacts 328 and/or the electrical interconnect 307 canbe, for example, nine-pin electrical interconnects, although anysuitable interconnect can be used. The motor assembly that drives theoperative device (e.g., impeller) of the catheter pump can beelectrically connected to the interface member 300 by way of one or moreelectrical cables, e.g., the conduits 302. In turn, the console 301 canbe coupled to a power source, which can drive the catheter pump motorassembly by way of the interface member's contacts 328 and theelectrical conduits 302 connecting the interface member 300 to the motorassembly. The electrical component 340 can also include communicationsinterconnects configured to relay electrical signals between the console301 and the catheter pump motor assembly or other portions of thecatheter assembly 100A. For example, a controller within the console 301(or interface member) can send instructions to the catheter pump motorassembly via the electrical component 340 between the console 301 andthe interface member 300. In some embodiments, the electrical component340 can include interconnects for sensors (such as pressure ortemperature sensors) within the catheter assembly 100A, includingsensors at the operative device. The sensors may be used to measure acharacteristic of the fluid in one or more of the tubes (e.g., salinepressure). The sensors may be used to measure an operational parameterof the system (e.g., ventricular or aortic pressure). The sensors may beprovided as part of an adjunctive therapy.

The electrical component 340 within the interface member 300 can be usedto electrically couple the cable (and the motor assembly, sensors, etc.)with the corresponding interconnects 307 in the console 301. Forexample, one or more internal connectors 346 and 348 on the second sideof the electrical component 340 may provide electrical communicationbetween the contacts 328 (configured to couple to the interconnects 307of the console 301) and the catheter assembly 100. For example,electrical cables (e.g., the conduits 302) can couple to a firstinternal connector 346 and a second internal connector 348. The internalconnectors 346, 348 may electrically communicate with the contacts 328on the first side of the electrical component 340, which in turncommunicate with the interconnects 307 of the console 301.

In various embodiments, the electrical component 340 is fluidly sealedto prevent the internal electronics from getting wet. This may beadvantageous in wet and/or sterile environments. This may alsoadvantageously protect the electronics in the event one of the fluidtubes leaks or bursts, which is a potential risk in high pressureapplications.

In addition, the electrical component 340 (e.g., PCB) can includevarious electrical or electronic components mounted thereon. As shown inFIG. 6B, for example, two pressure sensors 344 a, 344 b can be mountedon the electrical component 340 to detect the pressure in the pump tubesegments 324 a, 324 b. The pressure sensors 344 a, 344 b may be used tomonitor the flow of fluids in the tube segments 324 a, 324 b to confirmproper operation of the heart pump, for example, confirming a properbalance of medical solution into the catheter body and waste out of thecatheter body. Various other components, such as a processor, memory, oran Application-Specific Integrated Circuit (ASIC), can be provided onthe circuit board. For example, respective pressure sensor ASICs 345 a,345 b can be coupled to the pressure sensors 344 a, 344 b to process thesignals detected by the pressure sensors 344 a, 344 b. The processedsignals may be transmitted from the ASICs 345 a, 345 b to the console301 by way of internal traces (not shown) in the PCB and the contacts328.

Priming and Infusate System and Apparatus

One embodiment of an infusate system 1300 is illustrated in FIG. 7 .Various components described herein can be understood in more detail byreferencing the patent applications incorporated by reference herein.The infusate system 1300 can be configured to supply treatment and/orlubricating fluids to the operative device of the catheter assembly(e.g., an impeller assembly 116), and to remove waste fluid from theassembly. Furthermore, as explained herein, an elongate body 174 can beslidably disposed over a catheter body 120, such that there may be gapsor channels between the outer surface of the catheter body 120 and theinner surface of the elongate body 174. Such gaps or channels cancontain air pockets harmful to the patient during a medical procedure.In addition, the lumen or lumens extending within the catheter body 120also can contain air pockets harmful to the patient. Thus, it isdesirable to expel air from both the lumens within catheter body 120 andthe gaps or channels disposed between the elongate body 174 and thecatheter body 120 before conducting a treatment procedure.

The system 1300 of FIG. 7 may be configured to supply fluid to thecatheter assembly during treatment, to remove waste fluid duringtreatment, and/or to expel air from the elongate body 174, e.g., betweenthe inner surface of the elongate body 174 and the outer surface of thecatheter body 120 before treatment. In this embodiment, an interfacemember 1313 (similar to or the same as the interface member 300described herein, in some aspects) may be provided to connect variouscomponents of the catheter assembly, as discussed herein. An outersheath tubing 1303 a can extend from a fluid reservoir 1305 to a luer102 configured to be coupled to an infusate device. As shown in FIG. 7 ,the outer sheath tubing 1303 a can be configured to deliver fluid to theouter sheath, e.g., the space between the elongate body 174 and thecatheter body 120. The fluid reservoir 1305 may optionally include apressure cuff to urge fluid through the outer sheath tubing 1303 a.Pressure cuffs may be particularly useful in fluid delivery embodimentsusing gravity-induced fluid flow. The luer 102 can be configured todeliver infusate or other priming fluid to the elongate body 174 toexpel air from the elongate body 174 as described herein in order to“prime” the system 1300. In addition, a pressure sensor 1309 a, whichmay be disposed on a motor housing 1314, can be coupled to the outersheath tubing 1303 a to measure the pressure of the infusate or primingfluid flowing through the outer sheath tubing 1303 a and into the luer102. The motor housing 1314 illustrated in FIG. 7 may be the same as orsimilar to the motor assembly described above with reference to FIG. 2 ,for example, when the drive assembly 103 is coupled to the drivenassembly 101.

As illustrated in the embodiment of FIG. 7 , inner catheter tubing 1303b can extend between the motor housing 1314 and the fluid reservoir1305, by way of a T-junction 1320. The inner catheter tubing 1303 b canbe configured to deliver fluid to the lumen or lumens within catheterbody 120 during treatment and/or to expel air from the catheter 120 andprime the system 1300. A pumping mechanism 1306 a, such as a roller pumpfor example, can be provided along inner catheter tubing 1303 b toassist in pumping the infusate or priming fluid through the system 1300.As explained herein, the roller pump can be a peristaltic pump in somearrangements. In addition, an air detector 1308 can be coupled to theinner catheter tubing 1303 b and can be configured to detect any air orbubbles introduced into the system 1300. In some embodiments, a pressuresensor 1309 b can couple to inner catheter tubing 1303 b to detect thepressure of the fluid within the tubing. Additionally, a filter 1311 canbe employed to remove debris and other undesirable particles from theinfusate or priming fluid before the catheter body 120 is infused orprimed with liquid. In some embodiments, the air detector 1308, thepressure sensor 1309 b, and the pumping mechanism 1306 a can be coupledto the interface member 1313 described above (such as the interfacemember 300). One or more electrical lines 1315 can connect the motorhousing 1314 with the cassette 1313. The electrical lines 1315 canprovide electrical signals for energizing a motor or for powering thesensor 1309 a or for other components. To expel air from the catheterbody 120, infusate or priming fluid can be introduced at the proximalend of the catheter assembly. The fluid can be driven distally to driveair out of the catheter body 120 to prime the system.

In some aspects, a waste fluid line 1304 can fluidly connect thecatheter body 120 with a waste reservoir 1310. A pressure sensor 1309 c,which may be disposed on or coupled to the interface member 1313, canmeasure the pressure of the fluid within the waste fluid line 1304. Apumping mechanism 1306 b, such as a roller pump, for example, can becoupled to the interface member 1313 and can pump the waste fluidthrough the waste fluid line 1304 to the waste reservoir 1310.

FIG. 8 is an enlarged view of the priming apparatus 1400 shown in FIG. 2. As explained above, the priming apparatus 1400 may be disposed overthe impeller assembly 116A near the distal end 170A of the elongate body174A. The priming apparatus 1400 can be used in connection with aprocedure to expel air from the impeller assembly 116A, e.g., any airthat is trapped within the housing or that remains within the elongatebody 174A near the distal end 170A. For example, the priming proceduremay be performed before the pump is inserted into the patient's vascularsystem, so that air bubbles are not allowed to enter and/or injure thepatient. The priming apparatus 1400 can include a primer housing 1401configured to be disposed around both the elongate body 174A and theimpeller assembly 116A. A sealing cap 1406 can be applied to theproximal end 1402 of the primer housing 1401 to substantially seal thepriming apparatus 1400 for priming, i.e., so that air does notproximally enter the elongate body 174A and also so that priming fluiddoes not flow out of the proximal end of the housing 1401. The sealingcap 1406 can couple to the primer housing 1401 in any way known to askilled artisan. However, in some embodiments, the sealing cap 1406 isthreaded onto the primer housing by way of a threaded connector 1405located at the proximal end 1402 of the primer housing 1401. The sealingcap 1406 can include a sealing recess disposed at the distal end of thesealing cap 1406. The sealing recess can be configured to allow theelongate body 174A to pass through the sealing cap 1406.

The priming operation can proceed by introducing fluid into the sealedpriming apparatus 1400 to expel air from the impeller assembly 116A andthe elongate body 174A. Fluid can be introduced into the primingapparatus 1400 in a variety of ways. For example, fluid can beintroduced distally through the elongate body 174A into the primingapparatus 1400. In other embodiments, an inlet, such as a luer, canoptionally be formed on a side of the primer housing 1401 to allow forintroduction of fluid into the priming apparatus 1400.

A gas permeable membrane can be disposed on a distal end 1404 of theprimer housing 1401. The gas permeable membrane can permit air to escapefrom the primer housing 1401 during priming.

The priming apparatus 1400 also can advantageously be configured tocollapse an expandable portion of the catheter assembly 100A. The primerhousing 1401 can include a funnel 1415 where the inner diameter of thehousing decreases from distal to proximal. The funnel may be gentlycurved such that relative proximal movement of the impeller housingcauses the impeller housing to be collapsed by the funnel 1415. Duringor after the impeller housing has been fully collapsed, the distal end170A of the elongate body 174A can be moved distally relative to thecollapsed housing. After the impeller housing is fully collapsed andretracted into the elongate body 174A of the sheath assembly, thecatheter assembly 100A can be removed from the priming housing 1400before a percutaneous heart procedure is performed, e.g., before thepump is activated to pump blood. The embodiments disclosed herein may beimplemented such that the total time for infusing the system isminimized or reduced. For example, in some implementations, the time tofully infuse the system can be about six minutes or less. In otherimplementations, the infusate time can be less than 5 minutes, less than4 minutes, or less than 3 minutes. In yet other implementations, thetotal time to infuse the system can be about 45 seconds or less. Itshould be appreciated that lower infusate times can be advantageous foruse with cardiovascular patients.

Preparing a Percutaneous Heart Pump for Insertion into the Vasculature

As discussed herein and in the incorporated patent applications, invarious embodiments the heart pump is inserted in a less invasivemanner, e.g., using techniques that can be employed in a catheter lab.

Prior to insertion of the catheter assembly 100A of the heart pump,various techniques can be used to prepare the system for insertion. Forexample, as discussed in connection with FIG. 8 , the catheter assembly100A can be primed to remove gas that could be contained therein priorto any method being performed on the patient. This priming technique canbe performed by placing a distal portion of the catheter assembly 100Ain a priming vessel, such as the apparatus 1400. Thereafter, a media isdelivered into the catheter assembly 100A under pressure to displace anypotentially harmful matter, e.g., air or other gas, out of the catheterassembly 100A. In one technique, the apparatus 1400 is filled with abiocompatible liquid such as saline. Thereafter, a biocompatible liquidsuch as saline is caused to flow distally through the catheter assembly100 to displace air in any of the cavities formed therein, as discussedabove. A pressure or flow rate for priming can be provided that issuitable for priming, e.g., a pressure or flow rate that is lower thanthe operational pressure or flow rate.

In one technique, the biocompatible liquid is pushed under positivepressure from the proximal end through the catheter assembly 100A untilall gas is removed from voids therein. One technique for confirming thatall gas has been removed is to observe the back-pressure or the currentdraw of the pump. As discussed above, the priming apparatus 1400 can beconfigured to permit gas to escape while preventing saline or otherbiocompatible liquid from escaping. As such, the back-pressure orcurrent draw to maintain a pre-selected flow will change dramaticallyonce all gas has been evacuated.

In another technique, the priming apparatus 1400 can include a source ofnegative pressure for drawing a biocompatible liquid into the proximalend of the catheter assembly 100A. Applying a negative pressure to thepriming apparatus 1400 can have the advantage of permitting the catheterassembly 100A to be primed separate from the pumps that are used duringoperation of the heart pump. As a result, the priming can be done inparallel with other medical procedures on the patient by an operatorthat is not directly working on the patient.

In another approach, a positive pressure pump separate from the pumpthat operates the heart pump can be used to prime under positivepressure applied to the proximal end. Various priming methods may alsobe expedited by providing a separate inlet for faster filling of theenclosed volume of the priming apparatus 1400.

Collapsing an Expandable Housing of a Fully Primed Catheter Assembly

A further aspect of certain methods of preparing the catheter assembly100A for insertion into a patient can involve collapsing the impellerhousing 116A. The collapsed state of the impeller housing 116A reducesthe size, e.g., the crossing profile, of the distal end of the system.This enables a patient to have right, left or right and left sidesupport through a small vessel that is close to the surface of the skin,e.g., using catheter lab-type procedures. As discussed above, in onetechnique the priming apparatus 1400 has a funnel configuration that hasa large diameter at a distal end and a smaller diameter at a proximalend. The funnel gently transitions from the large to the small diameter.The small diameter is close to the collapsed size of the impellerhousing 116A and the large diameter is close to or larger than theexpanded size of the impeller housing 116A. In one method, after thecatheter assembly 100A has been primed, the impeller housing 116A can becollapsed by providing relative movement between the priming apparatus1400 and the impeller housing 116A. For example, the priming housing1400 can be held in a fixed position, e.g., by hand, and the catheterassembly 100A can be withdrawn until at least a portion of the impellerassembly 116A is disposed in the small diameter segment of the primingapparatus 1400. Thereafter, the elongate body 174A of the sheathassembly can be advanced over the collapsed impeller assembly 116A.

In another technique, the catheter assembly 100A is held still and thepriming apparatus 1400 is slid distally over the impeller assembly 116Ato cause the impeller assembly 116A to collapse. Thereafter, relativemovement between the elongate body 174A and the impeller assembly 116Acan position the distal end 170A of the elongate body 174A over theimpeller assembly 116A after the catheter assembly 100A has been fullyprimed.

Control System

Various embodiments disclosed herein enable the control and managementof the catheter pump system during, e.g., preparation of the system andoperation of the system to pump blood through a patient. As explainedabove, conventional systems may provide the user or clinician withunclear guidance on how to proceed at various points during theprocedure. For example, the instructions provided with the packagedsystem may ask the user to verify various system states visually ormanually (e.g., instructing the clinician to verify that the cassettehas been inserted correctly, that the pump is ready to be primed, thatthe pump is ready to be used to pump blood, to manually verify a desiredpressure, etc.). The potential for unclear user instructions andguidance may cause the user to make mistakes that can be harmful topatient outcomes. Moreover, in conventional systems, it may take theuser or clinician a considerable amount of time to prepare the systemfor use, which may unduly delay the treatment procedure. In addition, inother systems, the user may not understand the priming process describedabove, and/or may not be trained to recognize that the system is readyto be primed or the status of a priming procedure.

Beneficially, the embodiments disclosed herein can address theseproblems by providing a control system that receives sensor data andautomatically controls the preparation and/or operation of the catheterpump system based on that sensor data. For example, in variousembodiments, the control system can automatically control the primingprocesses disclosed herein. The control system can instruct the user howto insert the cassette into the console, and, in response, the controlsystem can automatically determine whether or not the cassette has beeninserted correctly. The control system may monitor additional sensordata as well, such as pressure sensor data and/or bubble sensor data, todetermine that the cassette is correctly receiving (and/or sending)electronic data and/or fluid from (and/or to) the console. Once thecontrol system determines that the cassette has been correctly inserted,and that the cassette is in mechanical, fluidic, and/or electricalcommunication with the console, the control system can instruct a motorto drive a pump to deliver fluid distally through the catheter assemblyto drive gases from the catheter assembly.

Thus, the embodiments disclosed herein can advantageously manage thepriming processes described herein, based at least on sensor data fromone or more sensors. The mechanical arrangement of the cassette (e.g.,interface member or puck) and console described above can enableautomatic mechanical, fluid, and electrical connection between thecassette and console once the system detects proper insertion of thecassette into the console. Control of the priming and other preparatoryprocesses can beneficially reduce user errors, reduce preparation andpriming time, and improve controllability to avoid adverse events andimprove treatment outcomes.

Further, the control system can automatically determine whetherpreparation and priming is complete, and can begin operation to pumpblood based on sensor feedback and/or instructions provided by the userthrough a user interface. The control system can monitor the sensors todetermine problems that may arise and can initiate an alarm to indicateany problems. For example, in some embodiments, the motor may drawexcessive current that exceeds a predetermined threshold, which mayindicate a problem with the impeller (such as a bind). The controlsystem can recognize such an overcurrent condition and can initiate analarm to alert the clinician. In some embodiments, the control systemcan automatically shut off the motor in the event of such an overcurrentcondition. Moreover, the control system can control the supply of fluidto the patient and the removal of fluid (e.g., waste fluid) from thepatient. The control system can collect and analyze sensor datarepresentative of problems with fluid supply and/or waste withdrawal,such as clogged lines, etc. The system can initiate an alarm to the userbased on these conditions. Thus, the embodiments disclosed herein canalso enable automatic control of the operation of the catheter pump topump blood.

FIG. 9 illustrates a block diagram showing electrical connectionsbetween an embodiment of the console 301 and the cassette 300, which maybe further connected to one or more Hall sensor(s) 902, one or morepressure sensors 904, a motor 906, and one or more temperature sensors908. Examples of pressures sensors 904 include pressure sensors 344 a,and 344 b discussed above with respect to the detecting pressure in thepump tube segments. The console 901 can also include a display 954. Insome embodiments, the console 901 includes a separate alarm module 952.The alarm module can include an additional display and/or a speaker. Thealarm module 952 can also be integrated with the display 954.

The console 301 can include a hardware processor or controller 920 asdiscussed above. In an embodiment, the console 301 includes multiplehardware processors. For example, a separate hardware processor cancontrol the display 954. In some embodiments, the hardware processorsinclude ASICs as discussed above. In some embodiments, the console 301may be connected to a network for transferring data to a remote system.The console 301 can also include a memory 922 for storing systemconditions including parameters or thresholds for alarms or controllingother operations of the console 301. The console 301 can include adigital to analog converters 930 and 932. In an embodiment, the digitalto analog converter 932 is implemented entirely in hardware. Theconverters 930 and 932 can also operate as analog to digital converters.These converters can be used by the console 301 to communicate withexternal devices such as the motor 906, alarm 952 or the sensorsdiscussed above. The console 301 can also include additional circuitrysuch as power electronics 924 and the low pass filters 926. The powerelectronics 924 can for example provide power to motor 906. The filter926 may be used by the console 301 to selectively remove noise or selecta particular band of interest.

The console 301 can also include an electrical interface 328 forreceiving and sending signals from the console 301 to various componentsof the fluid handling system via the cassette or puck 300. The cassette300 may be the same as or similar to the interface member 300illustrated and described in detail above. The cassette 300 canelectrically connect with multiple sensors and motors.

FIG. 10 illustrates an embodiment of a control system 1000 for receivinginputs and controlling operation of the fluid handling system based onthe received inputs. The control system 1000 can also receive userinputs via the display 954 or other user input controls (not shown). Thecontrol system 1000 can be implemented using the hardware processor 920.The control system 1000 can include programming instructions toimplement some or all of the processes or functions described hereinincluding controlling operations of priming, providing instructions andsupport to caregivers, and improving the automated functionality. Theprogramming instructions of the control system 1000 can be saved in thememory 922. Some or all of the portions of the control system 1000 canalso be implemented in application-specific circuitry (e.g. ASICs orFPGAs) of the console 301.

FIG. 11 illustrates an embodiment of a process 1100 that can be managedusing the control system 1000. In an embodiment, the control system 1000automatically controls all aspects of the process 1000. For example, thecontrol system 1000 can receive inputs from the sensors discussed aboveand perform operations based on a determination that the parameters arein an operating range. The control system 1000 can also dynamicallyadapt based on detected parameters. In some embodiments, the controlsystem 1000 can operate semi-automatically in conjunction withoperations performed by a caregiver. The control system 1000 can guideoperations, perform checks, and provide instructions dynamically basedon detected problems, such as for example, a detection of bubbles.Accordingly, the control system 1000 can advantageously improve theoperations of the console 301 and the catheter pump system.

As discussed above, the control system 1000 can assist users in thepriming operation of the catheter pump system. In some embodiments, itmay be advantageous to have at least some or all of the aspects of thepriming operation automated using the control system 1000. The controlsystem 1000 can also provide feedback to the users to guide them insuccessfully completing the priming process. The control system 1000 canuse the sensor inputs to determine parameters of the system. Based onthe determined parameters, the control system 1000 can provide audio orvisual output. In an embodiment, the control system 1000 can generateuser interfaces for output to the display 954. The user interfaces caninclude feedback from the determined system parameters.

FIG. 12 illustrates an embodiment of a process 1200 for using thecontrol system 1000 to assist with the priming process. The process 1200can be implemented by any of the systems described herein. In anembodiment, the process 1200 is implemented by the control system 1000.The process can begin at block 1202 with the control system 1000generating one or more user interfaces and sending the user interfacesto the display. The user interface can include instructions for a userto prepare for the priming process. Example user interfaces aredescribed in detail below with respect to FIG. 14 to FIG. 51 . Thecontrol system 1000 can also receive inputs from selection by a user onthe generated user interfaces.

At block 1204, the control system 1000 can detect electrical signalsfrom various hardware components of the fluid handling system inresponse to a user following a first set of instructions. For instance,the control system 1000 can monitor electrical signals from acombination of the pressure sensor(s) 904, temperature sensor(s) 908,Hall sensor(s) 902, and other components of the fluid handling system.In some embodiments, the control system 1000 can determine systemparameters or conditions from the received electrical signals at block1206. System parameters may include flow rate, pressure differences,bubble detection, motor speed, motor current, temperature of the motor,temperature inside the console, etc.

The control system 1000 can also monitor a connection state of thevarious components of the fluid handling system. For example, thecontrol system 1000 can detect whether the cassette 300 is properlyattached to the console 301. The control system 1000 can also determineif a saline bag is empty as discussed herein. The specific parametersand operation of the control system 1000 is described in more detailbelow with respect to the user interfaces.

At block 1208, the control system 1000 can determine whether the usercan proceed to the next step or if there is a problem with the systemconditions. For example, if the control system 1000 determines that thepuck is not properly attached, the control system 1000 can generate analarm at block 1210. The alarm can be generated as an audio alarm and/ordisplayed on the display. The control system 1000 can also detect otherconditions, such as a bubble in the line, using an optical or acousticsensor or the like. Some of these conditions may not be readily apparentto the users and may result in malfunction or improper therapeuticoperation of the catheter pump system. Accordingly, the control system1000 can improve the operation of the catheter pump system bydetermining system conditions based on electrical and mechanical eventsthat may not have been detected in the absence of the control system1000.

If at block 1208, the control system 1000 determines that the user wassuccessful in following the instructions based on the determined systemconditions, the control system 1000 can determine if all the steps ofpriming are completed at block 1212. If not completed, the controlsystem 1000 can generate another user interface indicating a next set ofinstructions. The generated user interface can also indicate status ofthe system. For example, the generated user interface can indicate flowrate, motor current, motor speed, time remaining for priming, cassetteconnected. In some embodiments, the control system 1000 canautomatically carry out some of the instructions based on successfulcompletion of previous instructions. For example, when the controlsystem 1000 determines that a cassette is detected and properlyattached, the control system 1000 can automatically start pumping fluidto prime the system.

Accordingly, the control system 1000 can assist a user in completing thepriming operation. The control system 1000 can maintain a system statein the memory throughout the operation of the process 1200. The systemstate can include parameters described herein including connection stateof various components.

FIG. 13 illustrates an embodiment of a process 1300 for controllingoperation of the motor 906 using the control system 1000. In anembodiment, the motor 906 is the motor that drives the impeller. Forexample, in some embodiments, the motor 906 can be disposed outside thebody of the patient, and can rotate a drive shaft extending through thecatheter to drive the impeller. In other embodiments, the motor can beminiaturized and inserted into the body, with one or more wiresextending through the catheter to connect the motor 906 with the controlsystem 1000. In some embodiments, the control system 1000 can implementthe process 1300 for other motors of the system such as the peristalticpump motor that pumps saline solution for lubrication. Accordingly, thecontrol system 1000 can use the process 1300 for controlling many motorsof the catheter pump system.

The process can begin at block 1302 with the control system 1000 sendinga drive signal to a motor. The drive signal can be a low power controlsignal to activate the motor 906. The motor 906 can receive power forits operation from another source. In response to receiving the drivesignal, the motor can begin its operation. In some embodiments, it maybe advantageous to monitor the operation of the motor 906 for protectingthe motor 906. Monitoring the motor can also reveal system conditions asdiscussed above including, for example, detection of a blockage in aline.

Thus, at block 1304, the control system 1000 can monitor variouselectrical signals from the motor, sensors, and other components thatcan directly or indirectly provide indication of operation of the motor906.

At block 1306, the control system 1000 can determine parameterscorresponding to the received electrical signals. Parameters can includemotor speed, motor current, peristaltic pump speeds, pressure sensoroutputs, temperature sensor output, bubble detector status, batteryvoltage, battery charge level, and battery temperature. The controlsystem 1000 can store these parameters over time to monitor change inthe state of the catheter pump system over time.

Further, at block 1306, the control system 1000 can determine if any ofthe parameters discussed above exceeds a predetermined threshold. In anembodiment, the control system 1000 may prevent the motor current fromexceeding a motor current threshold of 1.2 A. In some embodiments, themotor current threshold can be in a range of 0.5 A to 5 A, 0.5 A to 3 A,0.5 A to 2.5 A, 1 A to 3 A, or 1 A to 2 A. The control system can alsocompare the measured motor speed with predetermined values stored in thememory. The thresholds may vary depending on the size of the motor andother motor characteristics. In some embodiments, the control system1000 calculates flow rate based on the readings from the pressuresensor, such as the outer sheath pressure sensor (which may comprise acolumn of fluid that extends distally through the catheter body) and thecatheter motor speed. The control system 1000 can use a lookup table forthe relationships between the flow rate, motor speed, and pressure.Based on these stored parameters, the control system 1000 can correlatethe flow rate, pressure, with motor speed to determine systemconditions. For example, if the motor is drawing large current, but thelarge current is not translated into flow rate, the control system 1000can determine an existence of a system condition, such as blockage or abind in the impeller and/or drive shaft.

In some embodiments, when the parameters fall outside of predeterminedoperating parameters, the control system 1000 can modify the drivesignal to the motor. For example, when the control system 1000determines that the motor has stopped spinning based on a measured motorspeed or if the motor 906 is drawing excessive current, the controlsystem 1000 can generate an alarm and may switch to a backup motor or asecondary console.

The control system 1000 can also compare the motor current and motorspeed, for example, in revolutions per minute with a lookup table. Thelookup tables can be stored in the memory. If the motor current is belowor above a certain predetermined range for a particular motor speed, thecontrol system 1000 can generate an alarm.

In some embodiments, the control system 1000 can determine that thecassette 300 has been removed or connection with the cassette 300 hasbeen lost. The control system 1000 can stop the motor 906 in response tothe detection that connection with the cassette 300 has been lost. Asdiscussed above, the motor 906 can be the impeller motor. Stopping theimpeller motor when the connection with the cassette is lost may beadvantageous in some embodiments to protect the components andtherapeutic efficacy of the fluid handling system.

Alarm can be audio and/or visual. The control system 1000 can generate auser interface with the alarm and send it to the display. In someembodiments, at block 1308, the control system 1000 can reduce power orincrease power supplied to the motor based on the determinations of atleast one of the following: the flow rate, pressure, motor current. Thecontrol system 1000 can also stop sending the drive signal to the motorif the parameters exceed threshold.

FIG. 14 illustrates an embodiment of a startup user interface. Thestartup user interface can include multiple active links correspondingto operation of the catheter pump system and/or the fluid handlingsystem. In the illustrated example, the startup user interface includesactive links for performing a new procedure, emergency restart, and shutdown. The startup user interface can also display system status. In theexample, the startup user interface shows a text, “System ready.” Thetext can be generated by the control system 1000 in response detectingthat the cassette 300 is properly attached to the console 301. Thecontrol system 1000 can also generate the text based on determination ofother system parameters discussed herein.

FIG. 15 illustrates an embodiment of a system setup user interface forchanging settings related to the console. In an embodiment, the systemsetup user interface can be used by caretakers to change alarmconditions described herein. The setup user interface can also includean active link for testing the system. In the illustrated example, whena user selects the “Self Test” link, the control system 1000 can runmultiple checks on the components of the fluid handling system includingthe console to determine any problems. For example, the control system1000 can check for battery status, check motor(s) by doing a sample runand measuring motor parameters, such as speed, power, current drawn bythe motor. In some embodiments, the control system 1000 can determineflow rate to determine if there are any occlusions. Flow rate can becalculated based on pressure differences measured by the pressuresensors.

FIG. 16 illustrates an embodiment of save data user interface generatedby the control system 1000. The save data user interface can enableusers to save the measurements from the console on to an external drive.In some embodiments, the control system 1000 can send stored data over anetwork to a computing device. The control system 1000 can also receiveinstructions for operation over the network. In an embodiment, thenetwork includes local network or internet or a combination of local andwide area network.

FIG. 17 illustrates an embodiment of a first prep screen user interfacegenerated by the control system 1000. The first prep screen userinterface can include instructions to enable a caretaker to prepare thefluid handling system. In the illustrated embodiment, the instructionsrelate to spiking and priming a 1 liter heparinized saline bag. In someembodiments, the control system 1000 may determine that instructionswere successfully carried out by the caretaker. For example, the controlsystem 1000 can run the pump and measure the pressure to determinewhether the saline bag is connected properly. The control system 1000can automatically move on to the next step in the process based on thesuccessful completion of the current instructions. In some embodiments,the control system 1000 can request input from the caretaker to move tothe next step of the process. The numeral (e.g. “1”) shown in the prepuser interface can indicate the current step or status.

FIG. 18 illustrates an embodiment of a second prep screen user interfacegenerated by the control system 1000. The second prep screen userinterface may correspond to a second set of instructions following thefirst set of instructions. As discussed above, the control system 1000can generate the second prep screen user interface and send it to thedisplay after a successful completion of the previous instructions asdetermined by the control system 1000. As illustrated, the userinterfaces can also include a back and forward link to enable caretakersto navigate the instructions. In an embodiment, the control system 1000can automatically navigate through the user interfaces based on thecurrent system state, which can be stored in the memory. In theillustrated user interface, the instructions correspond to placing apressure cuff on bag. The user interface can visually indicate thelocation of where the pressure cuff should go in relation to othercomponents of the fluid handling system. In some embodiments, thecontrol system 1000 can attempt to measure the pressure for detection ofwhether the pressure cuff was attached.

FIGS. 19 to 24 illustrate embodiments of user interfaces correspondingto instructions relating to insertion of cassette (or puck). Asdiscussed above, the control system 1000 can monitor if the instructionsare successfully followed based on received electrical signals. Forexample, in some embodiments, the control system 1000 can detect removalof puck from top tray based on a change in electrical connection betweenthe puck and the top tray. The change may be a measurement of current,resistance, or voltage. In other embodiments, the user may advance tothe next screen manually by engaging with the user interface. FIG. 20illustrates an example where the control system 1000 may request a userto perform an instruction and manually select the next link. In someembodiments, the control system 1000 can run a timer for eachinstruction and optionally display it on the user interface so that thenext task screen is automatically displayed.

In FIG. 21 , the user interface includes instructions corresponding tohanging waste bag on hook at bottom of console prior to attaching thecassette 300 with the console 301. The control system 1000 can monitorattachment of the cassette 300. If the user inserts the cassette 300before completion of the instructions, the control system 1000 cangenerate an alert. Monitoring attachment of the cassette 300 can beperformed via electrical signals. For example, when the cassette 300 isattached, an electrical circuit might close and cause current flow,which can be detected by the control system 1000. In some embodiments,attachment of the cassette 300 can be detected by measuring afixed-value resistor in an electrical circuit of the puck. Differentvalues of resistors can indicate different types of cassette connected.In some embodiments, the control system 1000 can change its operatingparameters based on the electrical circuit configuration in the puck.FIG. 22 illustrates user interface for instructions corresponding to thesixth step in the prepping process. In some embodiments, the controlsystem 1000 can selectively animate the instructions visually on theuser interface when multiple instructions are displayed on a singlesuser interface as shown.

FIG. 23 illustrates an embodiment of a user interface generated by thecontrol system 1000 including instruction to unclamp the line connectingto the pressurized saline bag. The control system 1000 can automaticallydetermine if the caretaker has unclamped the line. For example, thecontrol system 1000 can take pressure measurement from the pressuresensors discussed above and generate an alarm or an indication tounclamp the line before moving on to the next set of instructions.

FIG. 24 illustrates an embodiment of a user interface generated by thecontrol system 1000 including instructions to insert cassette 300 intothe console 301. In some embodiments, the fluid handling system mayrequire a certain amount of time to elapse after unclamping the line asinstructed in FIG. 23 . In the illustrated example, the elapsed time is15 seconds. The control system 1000 can include a timer and display anindication when the cassette is ready to be attached. The control system1000 can measure the pressure to determine if the saline has not filledthe tubing and generate an alarm indicator.

FIG. 25 illustrates an embodiment of a user interface generated by thecontrol system 1000 indicating that the cassette 300 was successfullyconnected with the console 301. In some embodiments, the control system1000 can automatically start the priming process responsive to detectingthe puck and display the indication of progress as shown in FIG. 26 .For example, the control system 1000 can send a signal to theperistaltic pump to operate at a particular rate for a period of time.In an embodiment, the speed is 30 rpm or less. The period of time can betwo minutes or less. The control system 1000 can also detect whether thestopcock to the outer sheath is opened before beginning the primingprocess.

The following disclosure describes some of the other parametersmonitored by the control system 1000 during the operations illustratedin the instructional user interfaces above. It further describes some ofthe system conditions identified based on the monitoring. For example,the control system 1000 can monitor waste pressure sensor. In oneembodiment, if the waste supply pressure is less than 200 mm Hg, thecontrol system 1000 can determine there is a blockage. In anotherembodiment, the waste supply pressure of less than 150 mm Hg mayindicate blockage. Further, a waste supply pressure of less than 200 mmHg may indicate blockage in the saline line. The control system 1000 canalso monitor saline supply pressure sensor. A saline supply pressure ofless than a leak threshold pressure value can suggest a leak or emptybag. The leak threshold pressure value can be 200 mm Hg. In someembodiments, the leak threshold pressure value is less than 200 mm Hg orgreater than 200 mm Hg. Furthermore, a saline supply pressure of greaterthan block threshold value may indicate a blockage in the saline line.The block threshold value can be 600 mm Hg. In some embodiments, theblock threshold pressure value is less than 600 mm Hg or greater than600 mm Hg. A saline supply pressure of less than 150 mm Hg can indicatethere is no saline flow to catheter. In some embodiments, the controlsystem 1000 can use a combination of measurements from the saline supplypressure and the waste pressure sensor to determine if there is a leak(for example, saline supply pressure less than 200 mm Hg and wastepressure sensor less than 100 mm Hg) or blockage (for example, salinesupply pressure>550 mmHg and waste pressure sensor<150 mmHg).Furthermore, in some embodiments, the control system 1000 can monitorouter sheath pressure during priming. An outer sheath pressure of lessthan 35 mm Hg during priming may be a result stopcock being closed orinfusion set clamp closed off or blockage in saline line. The controlsystem 1000 can indicate an alarm including particular problems based onthe detected conditions. The control system 1000 can also stop the primetimer until the condition is resolved.

FIG. 27 illustrates an embodiment of a user interface generated by thecontrol system 1000 indicating that the priming process has beencompleted. In an embodiment, the control system 1000 can determinewhether there are bubbles in the tube and indicate to the caretaker toremove the bubbles. In some arrangements, the caretaker can tap thedistal end of the priming vessel to cause the bubbles to exit the distalend of the system. In other arrangements, the control system 1000 canautomatically cause the fluid handling system to continue driving fluidthrough the catheter pump system, or to increase the pressure and/orflow rate of fluid through the system, in order to remove bubbles fromthe system prior to the treatment procedure.

As illustrated in the figures, the steps that require user input tocarry out operations shown in FIG. 11 may be complex and also prone toerrors. The errors can be caused by human operators or unforeseen systemor environment conditions. Further, any error in the operation of thefluid handling system may negatively affect treatment outcomes.Accordingly, the control system 1000 can provide an automated supportfor operating the fluid handling system. While in the above embodiments,the control system 1000 is described with respect to the primingoperation, the control system 1000 can also be programmed to providesupport and control other functions of the fluid handling systemdescribed in FIG. 11 , such as delivering the catheter to the patient,running the heart pump, and removing the catheter from the patient.

The control system 1000 can monitor multiple system parameters. Forexample, the control system can monitor motor speed, device motorcurrent, peristaltic pump speeds, pressure sensor outputs, temperatureoutput, bubble detector status, battery voltage, battery charge level,and battery temperature. Based on these parameters, the control system1000 can verify system conditions and operation. Further, the controlsystem 1000 can also use these parameters to control components, such asmotors, of the fluid handling system.

In some embodiments, the control system 1000 continuously monitors thefluid handling system including console 301 by reading inputs orcalculating parameters at a rate of greater than 1 Hz. In someembodiments, sampling frequency is greater than or equal to 10 Hz. Therate can also be less than 1 Hz. The control system 1000 can performthese measurements during any time or operation of the fluid handlingsystem. These operations can be performed using parallel processingand/or software or hardware interrupts.

In some embodiments, the control system 1000 monitors several inputssimultaneously to ensure successful operation of the fluid handlingsystem and for providing support during unexpected problems. The controlsystem 1000 can generate alarms or send signals when the fluid handlingsystem 100 deviates from its normal course of operation. The followingexamples illustrate how the control system 1000 generates alerts and/orcontrol operations of the fluid handling system during deviation fromoperating range.

FIG. 28 illustrates an embodiment of a user interface including an alerthistory during operation of fluid handling system. In an embodiment, thealert history user interface shown in FIG. 28 is generated by thecontrol system 1000 for display after specific processes, such aspriming, delivering, and the like are completed.

FIG. 29 illustrates an embodiment of a user interface for alerting theuser when the puck is disconnected. The control system 1000 can detectif the puck gets disconnected based on received or loss of electricalsignal as discussed above. The control system 1000 can generate a userinterface notifying the user of the condition and to enable the user torestart the system. The control system 1000 can guide the users toemergency restart or prepare to connect a secondary console. In responseto detection of puck disconnection, the control system 1000 canautomatically cut off or clamp saline supply lines. The control system1000 can also stop or maintain current to the motors depending on theprocess, such as, priming or delivering.

FIG. 30 illustrates a user interface generated by the control system1000 indicating that there is air in the saline supply line. The controlsystem 1000 can detect for bubbles using a bubble detector based on forexample, optical or sound wave sensors. Based on the detection ofbubble, the control system 1000 can generate the user interface shown inFIG. 30 . The control system 1000 can halt the operation of the fluidhandling system until the bubble is removed. In an embodiment, thecontrol system 1000 can automatically detect removal of bubble. Thecontrol system 1000 can also require user input for removal of bubble asshown in the illustrated figure.

FIG. 31 illustrates a user interface generated by the control system1000 based on a detection of temperature of the handle, in which themotor 906 may be disposed. Operation of the motor 906 within the handlecan generate significant heat, which may cause the patient discomfort.The control system 1000 can monitor the temperature of the handle usingone or more temperature sensors. In an embodiment, temperature sensorincludes a thermocouple. The control system 1000 can compare thetemperature with a predetermined threshold and generate the illustrateduser interface when the temperature exceeds the threshold. Thepredetermined threshold can be in a range of 30° C. to 60° C., in arange of 35° C. to 50° C., or in a range of 38° C. to 45° C. The controlsystem 1000 can provide instructions to the user based on the detectedtemperature. In an embodiment, the control system 1000 automaticallyshuts down some or all portions of fluid handling system (e.g., themotor 906) if the temperature continues to increase for a period of timeor a higher threshold value.

FIG. 32 illustrates an embodiment of a user interface generated by thecontrol system 1000 in response to monitoring outer sheath pressure. Insome embodiments, the control system 1000 can determine if there is ablockage in the outer sheath based on monitoring outer sheath pressuresensor. If the pressure is less than 50 mm Hg during operation, thecontrol system 1000 can determine there is a blockage and generate analert as shown in the illustrated figure. In some embodiments, if thepressure is less than 60 mm Hg, less than 45 mm HG, or less than 40mmHg, the control system 1000 can determine there is a blockage andgenerate an alert. The control system 1000 can provide instructions andenable the user to flush the outer sheath with heparinized saline toclear the line. In other embodiments, in response to the alert, thesystem 1000 can automatically drive fluid down the outer sheath toremove the blockage.

FIG. 33 illustrates an embodiment of a user interface generated by thecontrol system 1000 in response to monitoring saline flow that passesdistally to the impeller and cannula. The control system 1000 canmonitor saline flow using direct flow measurements or indirectmeasurements using pressure sensors as discussed above. Based on thesensor measurements, the control system 1000 can determine that there islittle or no saline flow to the catheter. Accordingly, the controlsystem 1000 can generate the illustrated user interface to provide auser with instructions on resolving the error.

FIG. 34 illustrates an embodiment of a user interface generated by thecontrol system 1000 in response to detecting outer sheath pressure. Asdiscussed above, the control system 1000 can monitor the outer sheathpressure from the pressure sensor. If the pressure is below a threshold,the control system 1000 can generate the illustrated user interface toprovide instructions to the user on resolving the error.

FIG. 35 illustrates an embodiment of a user interface generated by thecontrol system 1000 in response to monitoring the unlock button. Thecontrol system 1000 can monitor the unlock button using electricalconnection and if the button is pressed during an operation, the controlsystem 1000 can alert the user of the consequences.

FIG. 36 illustrates an embodiment of a user interface generated by thecontrol system 1000 based on monitoring of waste line pressure sensor.For example, the control system 1000 can determine if the waste bag isfull or clamped based on the readings of the waste pressure sensor. Thecontrol system 1000 can compare the waste pressure sensor with one ormore thresholds or a range. Based on the comparison, the control system1000 can determine that the waste bag is full or clamped. In someembodiments, the range is between 100 and 200 mm Hg. In otherembodiments, the range is between 200 and 760 mmHg. Further, if thewaste line pressure sensor goes below −30 mmHg or greater than 700 mmHg,the control system 1000 can determine that there might be a waste systemfailure. Accordingly, the control system 1000 can detect condition ofthe waste bag and generate the illustrated user interface, which can actas an alert or alarm to the user.

FIG. 37 illustrates an embodiment of a user interface generated by thecontrol system 1000 based on monitoring device in the patient. In someembodiments, the control system 1000 can continue to monitor thearterial pressure sensor following deactivation of the motor. If thesensor indicates that the device has not been removed after a certaintime has elapsed, the control system 1000 can generate the illustrateduser interface. The control system 1000 can also generate an alert orthe illustrated user interface based on the elapsed time after theimpeller had stopped. In some embodiments, if the impeller has beenrunning too long, the system 1000 can automatically shut off theimpeller and notify the user that the impeller has been stopped.Beneficially, automatically monitoring the time of the treatmentprocedure can reduce the risk of hemolysis or other negative patientoutcomes.

FIGS. 38, 39, and 40 illustrate embodiment of user interfaces generatedby the control system 1000 in response to monitoring temperature. Thehandle temperature was discussed above with respect to FIG. 31 . FIG. 40shows another embodiment of the user interface corresponding to handletemperature. The control system 1000 can also monitor motor temperature,the control board temperature, and the battery board temperature. It maybe advantageous to monitor temperature to ensure that it does not exceedsafe ranges. The control system 1000 can monitor temperature usingtemperature sensors such as thermocouple or the like.

FIG. 41 illustrates an embodiment of a user interface generated by thecontrol system 1000 in response to monitoring connection status of thepuck as discussed above.

FIGS. 42 to 45 illustrate an embodiment of user interfaces generated bythe control system 1000 in response to monitoring cannula position. Itcan be important to position the cannula accurately in order to provideadequate pumping support to the heart. For example, in left ventricularassist procedures, it can be important to place the cannula across theaortic valve such that the cannula inlet is disposed in the leftventricle and the cannula outlet is disposed in the aorta. The cannulaposition inside the patient may not be directly visible to the caregiverwithout an imager. Accordingly, the control system 1000 can indirectlythrough measurements determine if the position of the cannula isincorrect. For example, the control system 1000 can measure motorcurrent. The high motor current may be a result of incorrect positioningor alignment of the cannula and impeller. It may also be a result ofexcessive bending of the catheter. The control system can accordinglyalert the user when motor current is above a specific threshold to checkpositioning and alignment. Flow rate and/or pressure may also beaffected by incorrect cannula position. For example, if the cannula isdisposed completely within the left ventricle or completely within theaorta, then the flow profiles will be different from the flow profilesgenerated when the cannula is disposed across the aortic valve. Thus,the control system may also monitor flow rate based on flow rate and/orpressure measurements. Further, the frequency and/or amplitudemodulation of motor parameters may also be used by the control system1000 to determine cannula position. Similarly, the control system 1000can also monitor the current drawn by a saline pump and/or waste pumpand the corresponding output of the pumps. The control system 1000 canautomatically stop the pumps if they exceed threshold values. The userinterface can instruct the clinician to reposition the cannula. Thesystem 1000 can continuously monitor the cannula position until thecannula is positioned correctly (e.g., across the aortic valve). Thesystem 1000 can then indicate that the cannula is positioned correctly.In response to the indication, the system 1000 can automaticallycontinue running, or the system 1000 can prompt the user to manuallycontinue the procedure.

The control system 1000 can also determine if a component of the fluidhandling system 100 has failed. For instance the control system 1000 candetermine that a pressure sensor, such as an outer sheath pressuresensor has failed. The control system 1000 can acquire the pressurereading from the outer sheath pressure sensor and if it is less than −20mmHg or greater than 300 mmHg, it is likely that the pressure sensor hasfailed.

The control system 1000 can measure flow rates based on pressuredifference and/or motor speed. Further, in some embodiments, the controlsystem 1000 can generate an alarm when the flow rate goes outside of athreshold range. A flow rate outside of the threshold range may indicatean issue with the patient condition, or with the positioning of thecannula. The control system 1000 can generate an alert to the caretakeror a secondary computer system to take a blood pressure measurementbased on the flow rate. The control system 1000 can also measure motorcurrent. The optimal range of motor currents and speed for particularprocesses of FIG. 11 may be stored in a lookup table. The control system1000 can determine that the motor current is increasing, but the speedof the impeller is the same. Based on this determination, the controlsystem 1000 can identify that the system may be operating outside of itsoptimal condition.

The ranges and numerical values discussed above may be a function of thefluid handling system, patient characteristics, among others.Accordingly, the numerical values can vary as will be understood by aperson skilled in the art.

What is claimed is:
 1. A fluid handling system comprising: a consoleconfigured to connect with a first electrical interface that isconfigured to connect to a plurality of components of the fluid handlingsystem, the console including a second electrical interface configuredto connect with the first electrical interface, a display, and one ormore hardware processors; a catheter assembly; a biocompatible fluidsource; a waste fluid line; and a control system comprising the one ormore hardware processors and a non-transitory memory storinginstructions that, when executed, cause the control system to: detect anelectrical signal from a first component of the plurality of componentsof the fluid handling system responsive to a caretaker performing afirst instruction; determine a system state of the fluid handling systembased at least in part on the electrical signal from the firstcomponent; compare the system state with a predetermined state conditioncorresponding to said first instruction; and output an indication on thedisplay of the system state.
 2. The fluid handling system according toclaim 1, wherein the instructions further cause the control system togenerate on the display a first user interface including a visualindication of the first instruction.
 3. The fluid handling systemaccording to claim 2, wherein the instructions further cause the controlsystem to generate on the display a second user interface including avisual indication of a second instruction based at least on thecomparison indicating that the system state is within predeterminedstate condition and the first instruction is completed.
 4. The fluidhandling system according to claim 1, wherein the instructions furthercause the control system to generate an alarm based at least on thecomparison indicating that the system state is not within predeterminedstate condition.
 5. The fluid handling system according to claim 1,further comprising a motor for driving a percutaneously insertable pumpfor bodily fluids, wherein the instructions further cause the controlsystem to: determine a temperature of an impeller motor that rotates theimpeller to pump blood and shut off the impeller motor responsive to thedetermination of the temperature of the impeller motor.
 6. The fluidhandling system according to claim 5, wherein the instructions furthercause the control system to determine a current drawn by the motor andshut off the motor if the current drawn exceeds a predeterminedthreshold.
 7. The fluid handling system according to claim 1, whereinthe plurality of components comprises a catheter, and the instructionsfurther cause the control system to: determine a flow state of fluid inthe catheter and trigger an alarm based if the flow state is indicativeof a blockage.
 8. The fluid handling system according to claim 1,wherein the plurality of components comprises a priming pump and thecatheter assembly, and wherein the instructions further cause thecontrol system to cause the priming pump to use a positive pressure toprime the catheter assembly with a biocompatible fluid.
 9. The fluidhandling apparatus according to claim 8, wherein the instructionsfurther cause the control system to monitor a back pressure or currentdraw of the priming pump and terminate the priming if the back pressureor current draw exceeds a predetermined threshold.
 10. The fluidhandling system according to claim 1, wherein the plurality ofcomponents comprises a priming pump and the catheter assembly, andwherein the instructions further cause the control system to cause thepriming pump to use a negative pressure to prime the catheter assemblywith a biocompatible fluid.
 11. The fluid handling apparatus accordingto claim 10, wherein the instructions further cause the control systemto monitor a back pressure or current draw of the priming pump andterminate the priming if the back pressure or current draw exceeds apredetermined threshold.
 12. The fluid handling system according toclaim 1, wherein the plurality of components comprises the catheterassembly and a primer housing for housing at least a portion of thecatheter assembly during a priming operation.
 13. The fluid handlingsystem according to claim 12, wherein the primer housing comprises atapered portion configured to compress at least a portion of thecatheter assembly from an expanded configuration to a collapsedconfiguration, the collapsed configuration having a smaller diameterthan the expanded configuration.
 14. The fluid handling system accordingto claim 12, wherein the catheter assembly comprises an expandableimpeller.
 15. The fluid handling system according to claim 1, furthercomprising a sensor for detecting air bubbles and wherein theinstructions further cause the control system to control the sensor todetect the presence of air bubbles in the catheter assembly.
 16. Thefluid handling system according to claim 1, wherein the instructionsfurther cause the control system to automatically begin a primingoperation upon the system state being a predetermined condition.
 17. Thefluid handling system according to claim 1, further comprising at leastone sensor for detecting a condition of the waste fluid line.
 18. Thefluid handling system according to claim 1, wherein the instructionsfurther cause the control system to generate on the display an alerthistory for showing a history of alert conditions of the fluid handlingsystem.
 19. A fluid handling system comprising: a console configured toconnect with a first electrical interface that is configured to connectto a plurality of components of the fluid handling system, the consoleincluding a second electrical interface configured to connect with thefirst electrical interface, a display, and one or more hardwareprocessors; a percutaneously insertable pump for bodily fluids; and acontrol system comprising the one or more hardware processors and anon-transitory memory storing instructions that, when executed, causethe control system to: detect an electrical signal from a firstcomponent of the plurality of components of the fluid handling systemresponsive to a caretaker performing a first instruction; determine asystem state of the fluid handling system based at least in part on theelectrical signal from the first component; compare the system statewith a predetermined state condition corresponding to said firstinstruction; output an indication on the display of the system state;detect a connection state between the first electrical interface and theconsole; and begin a priming the percutaneously insertable pump based onthe detected connection state between the first electrical interface andthe console and the determined system state.
 20. A fluid handling systemcomprising: a console configured to connect with a first electricalinterface that is configured to connect to a plurality of components ofthe fluid handling system, the plurality of components including acatheter assembly and a primer housing for housing at least a portion ofthe catheter assembly during a priming operation, the console includinga second electrical interface configured to connect with the firstelectrical interface, a display, and one or more hardware processors;and a control system comprising the one or more hardware processors anda non-transitory memory storing instructions that, when executed, causethe control system to: detect an electrical signal from a firstcomponent of the plurality of components of the fluid handling systemresponsive to a caretaker performing a first instruction; determine asystem state of the fluid handling system based at least in part on theelectrical signal from the first component; compare the system statewith a predetermined state condition corresponding to said firstinstruction; and output an indication on the display of the systemstate.